Staar Surgical Co.
FDA adverse event reports naming Staar Surgical Co. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: STAAR SURGICAL CO..
- Total reports
- 9,648
- Deaths
- 0
- Injuries
- 3,147
- Malfunctions
- 5,957
Reports per year
Source: FDA adverse event reports by year received, 2002–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Intraocular LensHQL6,999
- Lens, Intraocular, PhakicMTA1,344
- Lens, Guide, IntraocularKYB914
- Folders And Injectors, Intraocular Lens (Iol)MSS354
- Unit, PhacofragmentationHQC33
- Intraocular Pressure Lowering ImplantOGO2
- Treadmill, PoweredIOL1
- Implant, Eye ValveKYF1
- Stent, CoronaryMAF1
- Lens, Intraocular, Toric OpticsMJP1
Recent recalls
- 2013-07-17TerminatedMaterial/Component Contamination
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
- 2013-07-17TerminatedMaterial/Component Contamination
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
- 2011-06-29TerminatedOther
Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.
- 2005-08-06TerminatedOther
Staarvisic II Sodium Hyaluronate, 0.8 mL
Sterility may be compromised.
- 2005-04-27TerminatedOther
STAAR Phaco Tubing Kit
Complaints of leaking with question of sterility and risk of infection in eye.
- 2004-07-20TerminatedOther
MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
- 2004-07-20TerminatedOther
MicroSTAAR Injector, MSI-PF Packed ten per box.
Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
- 2004-07-20TerminatedOther
STAAR Surgical Intra Occular Lens, Collamer.
Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
- 2004-02-18TerminatedOther
Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
Risk of hyperopic refractive changes.
- 2004-01-29TerminatedOther
MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
Increased numbers of lens tears during placement of lens into eye.
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