Excimer Laser System
Unknown
Recent MDR events
13,777 adverse event reports on file
- WaveLight EX500 Excimer LaserJul 31, 2026InjuryWavelight Gmbh3003288808-2026-00319
- WaveLight EX500 Excimer LaserJul 31, 2026InjuryWavelight Gmbh3003288808-2026-00318
- STAR S4 IRJul 31, 2026MalfunctionAmo Manufacturing Usa, Llc3012236936-2026-000228
- WAVELIGHT EX500 EXCIMER LASERJul 22, 2026MalfunctionWavelight Gmbh3003288808-2026-00309
- WAVELIGHT EX500 EXCIMER LASERJul 22, 2026InjuryWavelight Gmbh3003288808-2026-00312
- WAVELIGHT EX500 EXCIMER LASERJul 17, 2026InjuryWavelight Gmbh3003288808-2026-00307
- WAVELIGHT EX500 EXCIMER LASERJul 15, 2026InjuryWavelight Gmbh3003288808-2026-00303
- WAVELIGHT EX500 EXCIMER LASERJul 15, 2026InjuryWavelight Gmbh3003288808-2026-00304
- UNK_IFS_FEMTOSECOND LASERJul 15, 2026InjuryAmo Manufacturing Usa, Llc3012236936-2026-000204
- UNK_IDESIGN AWS SYSTEMJul 15, 2026InjuryAmo Manufacturing Usa, Llc3012236936-2026-000204
Event type breakdown
Recalls
29 recall events for this product code
- Nidek IncTerminatedJun 4, 2015
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest.
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Z-1710-2015 · View FDA record ↗ - Nidek IncTerminatedNov 17, 2014
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII.
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
Z-0223-2015 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedOct 22, 2013
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC,
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Z-0046-2014 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedOct 22, 2013
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Z-0047-2014 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedOct 22, 2013
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing U
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Z-0048-2014 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedOct 22, 2013
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Z-0049-2014 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedJun 13, 2013
STAR S3 ActiveTrack Excimer System (STAR S3)
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Z-1539-2013 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedJun 13, 2013
STAR S4 with Variable Spot Scanning Excimer System (STAR S4)
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Z-1540-2013 · View FDA record ↗ - Abbott Medical Optics, Inc.TerminatedJun 13, 2013
STAR S4 IR Excimer System (STAR S4 IR)
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Z-1541-2013 · View FDA record ↗ - AMO Manufacturing USA, LLCTerminatedAug 9, 2011
STAR S4 IR Excimer Laser System; Software Version 5.00
Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version.
Z-2965-2011 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Wavelight Gmbh
PRESSATH Bavaria, DE
Amo Manufacturing Usa, Llc
Milpitas, CA, US
Nidek Co., Ltd. Hamacho Plant
GAMAGORI, AICHI, JP
Technolas Perfect Vision Gmbh
Munchen Bavaria, DE
Carl Zeiss Meditec Ag (jena)
Jena Thuringia, DE
Nidek Incorporated
The Colony, TX, US
Wavelight Gmbh
ERLANGEN Bavaria, DE
Nidek Co., Ltd.
GAMAGORI, AICHI, JP
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
Bausch & Lomb Incorporated
Saint Louis, MO, US
Johnson & Johnson Surgical Vision, Inc.
Irvine, CA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
15 premarket approvals for this product code
- Carl Zeiss Meditec, Inc.Aug 11, 2006
P060004 · MEL 80 EXCIMER LASER SYSTEM
- Alcon Laboratories, Inc.Oct 10, 2003
P030008 · WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- Alcon Laboratories, Inc.Oct 7, 2003
P020050 · WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- Technolas Perfect Vision GmbHFeb 23, 2000
P990027 · TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
- Amo Manufacturing USA, LLCNov 19, 1999
P990010 · VISX EXCIMER LASER SYSTEM MODEL C STAR
- Lasersight Technologies, Inc.Nov 12, 1999
P980008 · LASERSCAN LSX EXCIMER LASER SYSTEM
- Technolas GmbH Perfect VisionSep 28, 1999
P970056 · BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
- Nidek Co., Ltd.Dec 17, 1998
P970053 · EC-5000 EXCIMER LASER SYSTEM