Lens, Contact, Polymethylmethacrylate, Diagnostic
Ophthalmic · 21 CFR 886.1385
Recent MDR events
9 adverse event reports on file
- RXSIGHT CONTACT LENSJun 12, 2026InjuryRxsight, Inc.3012712027-2026-00275
- RXSIGHT CONTACT LENSJan 8, 2026InjuryRxsight Inc.MW5181948
- RXSIGHT CONTACT LENSJan 8, 2026InjuryRxsight Inc.MW5181949
- RXSIGHT CONTACT LENSAug 8, 2025InjuryRxsight, Inc.3012712027-2025-00303
- DISPOSABLE VITRECTOMY LENS: FLATSep 15, 2020MalfunctionD.o.r.c. Dutch Ophthalmic Research Center Int.1222074-2020-00066
- DISPOSABLE VITRECTOMY LENS: MAGNIFYINGJul 8, 2020MalfunctionDutch Ophthalmic Usa1222074-2020-00047
- DISPOSABLE VITRECTOMY LENS: FLATDec 18, 2019MalfunctionD.o.r.c. Dutch Ophthalmic Research Center (interna1222074-2019-00049
- DISPOSABLE VITRECTOMY LENS: WIDE VIEWOct 11, 2019MalfunctionD.o.r.c. Dutch Ophthalmic Research Center (interna1222074-2019-00032
- DISPOSABLE VITRECTOMY LENS: WIDE VIEWOct 7, 2019MalfunctionD.o.r.c. Dutch Ophthalmic Research Center (interna1222074-2019-00031
Event type breakdown
Recalls
3 recall events for this product code
- Vortex Surgical Inc.Open, ClassifiedFeb 4, 2026
Volk Single Use Vitrectomy Lenses
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-1244-2026 · View FDA record ↗ - Volk Optical IncTerminatedMar 15, 2016
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602
The firm discovered that the incorrect lot number was engraved on the product.
Z-1177-2016 · View FDA record ↗ - Volk Optical IncTerminatedMay 28, 2015
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Z-1685-2015 · View FDA record ↗
Registered firms
57 firms currently registered for this product code
Phakos
Montreuil Seine-Saint-Denis, FR
Sterigenics Us Llc
Charlotte, NC, US
Ocular Instruments, Inc.
BELLEVUE, WA, US
Volk Optical Inc.
Mentor, OH, US
Eagle Labs, Llc
Saint Paul, MN, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Sterigenics Germany Gmbh
Wiesbaden Hesse, DE
Katena Products, Inc.
Parsippany, NJ, US
Iridex Corporation
MOUNTAIN VIEW, CA, US
Oculus Surgical Inc
Port St Lucie, FL, US
Bioteque Corporation Yilan Science Park Factory
Yilan City, TW
Sterlab
VALLAURIS Alpes-Maritimes, FR
510(k) clearances
41 clearances for this product code
- Rxsight, Inc.Sep 10, 2020
K201909 · RxSight Contact Lens
- PhakosOct 25, 2018
K173944 · Endocular Viewing Lenses and Silicone Ring
- Volk Optical, Inc.Aug 18, 2015
K151961 · Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
- Sensor Medical Technology, LLCDec 16, 2014
K142715 · Sensor Medical Family of Vitrectomy Lenses and Products
- Insight Instruments, Inc.Jun 29, 2005
K051630 · SUPER VIEW DISPOSABLE BIOM LENS SET
- Haag-Streit USA, Inc.Jun 7, 2005
K051103 · HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
- Volk Optical, Inc.Mar 28, 2005
K050623 · VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
- Dutch Ophthalmic Research Center (D.O.R.C.)Feb 20, 2004
K033950 · DORC VITRECTOMY LENSES, MODEL 1284 SERIES