MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ASPIRE IOL; INTRAOCULAR LENS

Model Number	EA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore not available for evaluation.Additional information regarding the event was requested, but not received.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, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.
Event or Problem Description
It was reported that upon delivery of an intraocular lens (iol) into the eye, the surgeon noticed the haptic was damaged.Under microscopic examination, the surgeon discovered the very tip of trailing haptic was missing and not in the eye, it was in the injector cartridge.The incision was enlarged to allow for removal of the iol and a successful intraoperative lens exchange was performed using a backup iol of the same model and diopter.Patient outcome is good.Additional information was requested, but not received.
Event or Problem Description
Additional information was received indicating the original implant was in the right eye.In the surgeon's opinion, the most likely cause of the iol damage is from the lens sticking in delivery device.

• Brand Name: ENVISTA ASPIRE 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 n park pl blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19392775
• Report Number: 0001313525-2024-00104
• Device Sequence Number: 12703269
• Product Code: HQL
• UDI-Device Identifier: 10757770608550
• UDI-Public: (01)10757770608550(17)260930(11)231001(10)3P26005
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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 Expiration Date: 09/30/2026
• Device Model Number: EA
• Device Catalogue Number: EAU2000
• Device Lot Number: 3P26005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: B+L INJECTOR SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female