MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INJECTOR; MANUAL INTRAOCULAR LENS INJECTOR, SINGLE-USE

Model Number	21987
Medical Device Problem Codes	Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hospital confirmed the product is not available for evaluation.The investigation of this event is in progress.A review of device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.
Event or Problem Description
A hospital reported that after implantation of an intraocular lens (iol) a crack was noticed in the optic of the lens.The lens was removed and resulted in an iris prolapse.The surgery was extended by 30 minutes with a back up lens implanted and 3 stitches being placed.Due to the complication the patient had to return to have an ozurdex placed at a later time.
Additional Manufacturer Narrative
The hospital confirmed the product is not available for evaluation.A review of device history record (dhr) did not identify any anomalies or non-conformities that could be related to this event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.
Additional Manufacturer Narrative
The product was returned; however, evaluation could not be performed due to the condition of the return.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Common Device Name: MANUAL INTRAOCULAR LENS INJECTOR, SINGLE-USE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; alternhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 23302877
• Report Number: 0001313525-2025-00189
• Device Sequence Number: 4783758
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)230713(11)261130(10)2315A1
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K192005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 21987
• Device Lot Number: 2315A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/10/2025; Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/02/2025; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA INTRAOCULAR LENS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown