MAUDE Adverse Event Report: BAUSCH + LOMB INC. AKREOS ADAPTAO INTRAOCULAR LENS

Model Number	ADAPTAO
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product is not available for evaluation as it remains implanted.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.
Event or Problem Description
A consumer reported that approximately 12 years post implantation the patient experienced decreased vision in their left eye and opacification was noted on the implanted intraocular lens (iol).The bcva measurements were noted to be prior to the event 6/7.5 (20/20) and 6/18 vision (20/60) after the opacification was noted.No secondary treatment was required to treat the event and the iol remains implanted as the patients other iol remains in good condition.

• Brand Name: AKREOS ADAPTAO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB INC.; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21858805
• Report Number: 0001313525-2025-00054
• Device Sequence Number: 12723065
• Product Code: HQL
• UDI-Device Identifier: 10757770485960
• UDI-Public: (01)10757770485960(17)120430
• Combination Product (Y/N): N
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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 Expiration Date: 04/30/2012
• Device Model Number: ADAPTAO
• Device Catalogue Number: ADAPTAOP2200
• Device Lot Number: 1912739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2009
• 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: VISCOAT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male