MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS

Model Number	21987
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, during the intraocular lens (iol) implant procedure the iol was unable to eject.Surgeon was unable to proceed without an iol, therefore, patient was left aphakic.Patient returned four days later and an iol of the same model was successfully implanted.This report references injector 2 of 2.Reference report numbers 0001313525-2024-00141, 0001313525-2024-00142 and 0001313525-2024-00143.
Additional Manufacturer Narrative
Investigation of this event is in progress.A final report will be submitted upon conclusion of investigation.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h10.The device was received and evaluated.Evaluation revealed the plungers upper tip broken with the plunger rod advanced up to the conical zone and protruding from the tip.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Corrective measures have been identified to mitigate future similar occurrences.Bausch & lomb will continue to monitor similar events to determine if additional actions are required.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS
• 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 ; 6362263220
• MDR Report Key: 19974192
• Report Number: 0001313525-2024-00144
• Device Sequence Number: 8461232
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)260831(10)2304C3
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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 Expiration Date: 08/31/2026
• Device Model Number: 21987
• Device Lot Number: 2304C3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA INTRAOCULAR LENS PRELOADED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown