MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS INTRAOCULAR LENS

Model Number	AO60
Medical Device Problem Codes	Calcified (1077); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Update to: the lens was returned and evaluated.Inspection under magnification showed the presence of a cloudy orange peel white deposit on the surface of the optic area and at a smaller degree on the haptics.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that approximately 6 years after implantation of an intraocular lens (iol), the patient noticed a decrease of vision and fuzziness in their left eye.The surgeon's findings were a calcified lens with against the rule astigmatism.Approximatively 4 months later, the lens was exchanged for a different model iol due to dislocation.A vitrectomy was performed due to vitreous strands.In the surgeon¿s opinion the likely cause of the iol dislocation was the calcification of the lens.The patient¿s outcome is good.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h6, h11 correction: d4, e1, h6 evaluation of device through optical inspection and other analytical methods determined that the opacification was due to the presence of round deposits on the anterior iol surface comprised primarily of calcium and phosphorous.Based on the information available, lens calcification represents a recognized inherent risk associated with the device and is considered the most probable cause of the reported event.

• Brand Name: AKREOS 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 n. park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22923215
• Report Number: 0001313525-2025-00173
• Device Sequence Number: 10223551
• Product Code: HQL
• UDI-Device Identifier: 10757770502063
• UDI-Public: (01)10757770502063(17)210630
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 06/30/2021
• Device Model Number: AO60
• Device Catalogue Number: AO60P2050
• Device Lot Number: 1859404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2018
• 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: 79 YR
• Patient Sex: Male
• Patient Race: White