MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS MICROINCISION IOL; INTRAOCULAR LENS

Model Number	MI60P
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The deice was not returned for evaluation.A review of the device history record 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 of this event could not be determined.
Event or Problem Description
It was reported that during insertion of an intraocular lens (iol) into the patient¿s eye, the iol ''shot'' out of injector and ruptured the capsular bag.The iol was removed intraoperatively, a vitrectomy was performed and the patient was left aphakic.The procedure time was extended.A follow-up procedure is planned to implant a different model iol.Additional information was requested but not received.
Additional Manufacturer Narrative
The lens was returned for evaluation.Microscopic examination of the lens found no visible defects.Based on the available information, the root cause of this event could not be determined.
Event or Problem Description
Additional information was received indicating a scleral fixated iol was performed and the patient is reportedly very pleased with the outcome.
Additional Manufacturer Narrative
Additional info: a3, b5, g3, g6, h2, h10/11.

• Brand Name: AKREOS MICROINCISION IOL
• 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 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17740704
• Report Number: 0001313525-2023-70109
• Device Sequence Number: 20348628
• Product Code: HQL
• UDI-Device Identifier: 10757770500847
• UDI-Public: (01)10757770500847(17)260430(11)230520(10)1P13303
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P060022
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2023

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: 04/30/2026
• Device Model Number: MI60P
• Device Catalogue Number: MI60P2150
• Device Lot Number: 1P13303
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/27/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2023
• 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: VISCOJECT BIO 1.8 INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male