Photocoagulator And Accessories
Ophthalmic · 21 CFR 886.4690
Recent MDR events
68 adverse event reports on file
- 25 Directional Laser ProbeJul 30, 2026MalfunctionSynergetics, Inc0001932402-2026-00001
- SYNERGETICS - 25GA DIRECTIONAL LASER PROBEJul 20, 2026InjurySynergetics, Inc.MW5190847
- VORTEX SURGICALJan 15, 2026MalfunctionVortex Surgical Inc.3013002167-2026-00003
- VORTEX SURGICAL INCJan 7, 2026MalfunctionVortex Surgical, Inc.3013002167-2026-00002
- OERTLI SWITZERLANDDec 2, 2025InjuryVortex Surgical Inc.3013002167-2025-00001
- 25 GA CURVED LASER PROBENov 7, 2025InjuryPeregrine Surgical Llc2529392-2025-00001
- 25 GA CURVED LASER PROBENov 7, 2025InjuryPeregrine Surgical Llc2529392-2025-00002
- 25GA ILLUMINATED DIRECTIONAL LASERJun 25, 2025InjuryBausch + Lomb0001932402-2025-00005
- TRUCURVE LASER PROBE FOR 25GA SURGERYMay 16, 2025InjuryBausch + Lomb, Inc.0001932402-2025-00002
- ALCON, ENGAUGEMar 19, 2025MalfunctionAlcon Laboratories, Inc.21641834
Event type breakdown
Recalls
32 recall events for this product code
- Vortex Surgical Inc.Open, ClassifiedFeb 4, 2026
Vortex Surgical
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Z-1245-2026 · View FDA record ↗ - Vortex Surgical Inc.Open, ClassifiedFeb 4, 2026
Oertli
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Z-1246-2026 · View FDA record ↗ - Vortex Surgical Inc.Open, ClassifiedDec 30, 2025
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Z-1004-2026 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedNov 21, 2025
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF:
XXX
Z-0581-2026 · View FDA record ↗ - Synergetics IncTerminatedJan 30, 2014
Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Z-0872-2014 · View FDA record ↗ - Synergetics IncTerminatedJan 30, 2014
23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Z-0873-2014 · View FDA record ↗ - Synergetics IncTerminatedJan 30, 2014
Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Z-0874-2014 · View FDA record ↗ - Synergetics IncTerminatedJan 30, 2014
Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallo
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Z-0875-2014 · View FDA record ↗ - Synergetics IncTerminatedJan 30, 2014
23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fall
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Z-0876-2014 · View FDA record ↗ - Synergetics IncTerminatedJan 30, 2014
25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Z-0877-2014 · View FDA record ↗
Registered firms
54 firms currently registered for this product code
Katalyst Surgical, Llc
Chesterfield, MO, US
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Midwest Sterilization Corp.
JACKSON, MO, US
Tecfen Medical
Santa Barbara, CA, US
Fci Sas
BESANCON Doubs, FR
Nidek Co., Ltd. Hamacho Plant
GAMAGORI, AICHI, JP
Synergetics, Inc.
O Fallon, MO, US
Harmac Medical Products, Inc./h3 De Tijuana, S. De Rl De C.v.
Tijuana Baja California, MX
Peregrine Surgical, Llc.
New Britain, PA, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
Nidek Co., Ltd.
GAMAGORI, AICHI, JP
Fci Sud
MAPOU LECLEZIO GOODLANDS Riviere du Rempart, MU
Vortex Surgical, Inc.
Saint Charles, MO, US
Alcon Research, Llc
Lake Forest, CA, US
510(k) clearances
30 clearances for this product code
- Vortex Surgical, Inc.Nov 3, 2022
K220263 · Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- Vortex Surgical, Inc.Dec 23, 2019
K191846 · MAXReach Laser Probe
- VitreQ BVMay 1, 2019
K182646 · Vitreq disposable laser probes, light fibers and Chandelier
- Peregrine Surgical , Ltd.Nov 14, 2013
K132614 · PEREGRINE CURVED ILLUMINATING LASER PROBE
- Peregrine Surgical , Ltd.Jun 26, 2013
K122997 · 23GA CURVED ILLUMINATING LASER PROBE
- Peregrine Surgical , Ltd.Apr 30, 2013
K122905 · PEREGRINE 23GA CURVED LASER PROBE
- Synergetics, Inc.Apr 23, 2012
K113857 · SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
- Alcon Research, Ltd.Oct 17, 2011
K110951 · 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA