MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS INTRAOCULAR LENS

Model Number	MI60L
Medical Device Problem Codes	Material Opacification (1426); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Macular Edema (1822); Visual Impairment (2138); Insufficient Information (4580)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is underway.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The consumer reported cloudy vision post bilateral implants.Reportedly, a yag procedure was performed, but it did not improve her vision.Additional information has been requested, but has not been received.This report references the patient's left eye.
Additional Manufacturer Narrative
Additional information: device manufacture date.The lens remains implanted; therefore, it is not available for evaluation.The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the information available, the exact cause of the reported event could not be conclusively determined.
Additional Manufacturer Narrative
Corrected information.Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.
Event or Problem Description
Additional information was received indicating that approximately eight years after implantation of the intraocular lens (iol) in the left eye, the iol was exchanged for a pmma rigid lens due to opacification of the initial iol.Reportedly, symptoms began 18 months after implantation.Additional information has been requested, but not received.Please refence report 0001313525-2016-00676 for the right eye.
Event or Problem Description
Additional information received indicating the capsular bag was removed.Allegedly, cystoid macular edema developed approximately 7 years after initial iol implantation.Additional information was requested, but not received.Reference report number 0001313525-2016-00676 for right (od) eye.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h6, h11.
Event or Problem Description
Additional information was received indicating that the secondary physician performed an additional yag procedure, and the patient was treated for multiple glaucoma procedures.Patient cancelled all follow up appointments and was last seen by secondary physician approximately 2 months prior to intraocular (iol) lens exchange performed by a different physician.

• 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: 6130199
• Report Number: 0001313525-2016-00677
• Device Sequence Number: 10945474
• Product Code: HQL
• UDI-Device Identifier: 10757770502841
• UDI-Public: (01)10757770502841(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/01/2016

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: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: MI60L
• Device Catalogue Number: MI60LP1900
• Device Lot Number: 1570824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided; 05/10/2024; 01/16/2025; 02/24/2025
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 12/27/2016; 06/07/2024; 02/12/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2015
• 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; Other
• Patient Age: 61 YR
• Patient Sex: Female