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

Model Number	AO60
Medical Device Problem Codes	Material Twisted/Bent (2981); Ejection Problem (4009)
Health Effect - Clinical Codes	Corneal Edema (1791); Insufficient Information (4580)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Trend analysis does not meet the upper control limits of 1 as this is the only complaint for corneal edema related to this device in the last 15 months.Based on the available information, the root cause could not be conclusively determined.
Event or Problem Description
It was reported that during implantation of an intraocular lens (iol), the lens came out of cartridge twisted and stuck on plunger.The incision was enlarged, an anterior vitrectomy was performed, and an anterior chamber iol was implanted.Sutures were required.Patient prognosis is good.Patient has not yet recovered, still has corneal edema.Additional information was requested, but not received.

• Brand Name: AKREOS ADVANCED OPTICS 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: 19260668
• Report Number: 0001313525-2024-00097
• Device Sequence Number: 12415863
• Product Code: HQL
• UDI-Device Identifier: 10757770502094
• UDI-Public: (01)10757770502094(17)261130(11)231203(10)1P32908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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 Model Number: AO60
• Device Catalogue Number: AO60P2200
• Device Lot Number: 1P32908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown