MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore is not available for evaluation.Additional information regarding the event was requested, but not received.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause could not be conclusively determined; however, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.
Event or Problem Description
It was reported that after delivery of an intraocular lens (iol) into the eye, the haptic broke off.The iol was removed, the incision was enlarged, a vitrectomy was performed, and sutures were required.The patient was left aphakic and surgery for a replacement iol was planned for a future date.Additional information was requested, but not received.
Additional Manufacturer Narrative
Based on additional information received, it was determined the device causality is unrelated and therefore, this event no longer meets reportability requirements and is no longer deemed reportable.
Event or Problem Description
Additional information was received indicating an anterior capsular tear occurred prior to insertion of the intraocular lens.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19167122
• Report Number: 0001313525-2024-00092
• Device Sequence Number: 17987491
• Product Code: HQL
• UDI-Device Identifier: 10757770531414
• UDI-Public: (01)10757770531414(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910056
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 10/31/2025
• Device Model Number: MX60E
• Device Catalogue Number: MXUE2250
• Device Lot Number: 3269629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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: BLIS INJECTOR SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown