Folders And Injectors, Intraocular Lens (Iol)
FDA adverse event reports and recall history for folders and injectors, intraocular lens (iol) (product code MSS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,316
- Deaths
- 0
- Injuries
- 2,012
- Malfunctions
- 3,281
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
- 2017-01-09TerminatedDevice Design
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
The intraocular lens could become lodged within the cartridge
- 2004-07-23TerminatedOther
Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
- TerminatedError in labeling
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.
The recommended storage temperature on the label is incorrect.
- Open, ClassifiedLabeling mix-ups
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.
RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
- TerminatedDevice Design
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.
Complaints concerning kinked haptics that were occurring during lens delivery.
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