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

Model Number	MI60P
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection found that the lens was cut in two (2) pieces across the optic, a small cut was located near the edge and a haptic was broken.The surface of the lens and haptics had an orange peel appearance.Analysis of the returned device was completed using optical inspection, laser confocal microscopy, scanning electron microscopy, and electron dispersive x-ray spectroscopy.It was determined that the opacification was due to the presence of patchy, textured or wrinkled deposits on the anterior iol surface comprised primarily of calcium and phosphorous.Additional deposits containing calcium and phosphorous were also sparsely observed on the posterior lens surface and the haptics.Results of the analysis can best be described as opacification due to calcification.The device history record (dhr) review did not find any non-conformities or anomalies 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 evaluated suspect device, the root cause is "known procedure complication".
Event or Problem Description
It was reported that when performing vitreoretinal (vr) surgery on a patient that had an intraocular lens (iol) implanted many years ago the surgeon noticed symmetrical marks on the optic of the lens.It was not possible to see through the lens to complete the vr surgery and the lens was explanted.Approximately ten (10) months prior to the lens explant, pitting was noticed on the surface of the lens and it is suspected that this was due to yag capsulotomy.Additional information was requested but not received.

• 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: 17815110
• Report Number: 0001313525-2023-70111
• Device Sequence Number: 2440138
• Product Code: HQL
• UDI-Device Identifier: 10757770500854
• UDI-Public: (01)10757770500854(17)230131
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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: 01/31/2023
• Device Model Number: MI60P
• Device Catalogue Number: MI60P2200
• Device Lot Number: 1042617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown