MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALENS ACCOMMODATING IOL; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number	AO1UV
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Contracture (1761); Blurred Vision (2137); Posterior Capsule Opacification (4807)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the day after implantation of an intraocular lens into the left eye, capsular fibrosis was observed.Five weeks after the onset of capsular fibrosis, asymmetric lens vaulting was observed, but not treated.It was also reported that the patient had developed progressively increasing astigmatism, up to 4 diopters by 2 months post-op, secondary to asymmetric lens vaulting.Approximately two and a half months after implantation of the initial iol, the lens was exchanged with a different model due to unresolved z-syndrome.In the surgeon¿s opinion, the most likely cause of the event is capsular fibrosis.
Additional Manufacturer Narrative
Although requested, the lens was not returned for evaluation.A 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 available information, the root cause of this event could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11: the device was returned in three pieces with half the optic missing.Visual and dimensional evaluation could not be performed due to the condition of the return.Based on the available information, the root cause of this event could not be determined.
Additional Manufacturer Narrative
Additional info: b4, b5, g3, h2, h6, h10, h11.Correction: b6, b7, h6, h11.Based on the available information, the root cause of the event could not be conclusively determined, however patient related factors may have caused or contributed to this event.
Event or Problem Description
Additional information was received through a consumer-submitted medwatch report, alleging that the anterior capsule contraction and z-syndrome associated with the initial iol resulted in permanent eye damage and lasting visual defects.B+l attempts to obtain additional information regarding this event was not successful.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Common Device Name: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n. park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19831356
• Report Number: 0001313525-2024-00128
• Device Sequence Number: 20676130
• Product Code: NAA
• UDI-Device Identifier: 10757770523778
• UDI-Public: (01)10757770523778(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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: 01/31/2026
• Device Model Number: AO1UV
• Device Catalogue Number: AO1UV-2600
• Device Lot Number: 6140703
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 01/30/2026
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/26/2024; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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 Age: 65 YR
• Patient Sex: Female