Lens, Guide, Intraocular
FDA adverse event reports and recall history for lens, guide, intraocular (product code KYB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 8,648
- Deaths
- 0
- Injuries
- 1,574
- Malfunctions
- 7,039
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-01-10Open, ClassifiedProcess design
Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
- 2009-07-14TerminatedProcess design
Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.
- 2008-09-23TerminatedMixed-up of materials/components
MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
- 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.
- 2004-01-29TerminatedOther
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.
- TerminatedProcess control
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
Monitor lens, guide, intraocular automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.