MAUDE Adverse Event Report: BAUSCH + LOMB TRULIGN TORIC POSTERIOR CHAMBER IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	BL1UT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Contracture (1761); Blurred Vision (2137); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately ten weeks after implantation an intraocular lens (iol) into the left eye, posterior and asymmetric lens vaulting was observed.It also was reported the patient developed uveitis glaucoma hyphema (ugh) syndrome.The iol was exchanged with a different model due to unresolved z-syndrome and capsular phimosis within a week of onset of symptoms.Yag capsulotomy was performed one day post iol exchange.In the explanting surgeon''s opinion, the likely cause of the event is capsular contraction.In the implanting surgeon''s opinion, the most likely cause of the event is size of the lens relative to the sulcus diameter, capsular fibrosis, and capsular phimosis.Patient outcome is good.
Additional Manufacturer Narrative
Although requested, 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, trend analysis, risk analysis and 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
The device was returned for evaluation.Microscopic examination was performed and found the lens cut in 2 pieces across the optic.One haptic is missing and was not found loose in the container.The product evaluation could not verify the failure mode.Dimensional inspection was performed.All measurements were within spec.Based on this evaluation and available information, the root cause of this event could not be determined, and our previous assessment remains the same.

• Brand Name: TRULIGN TORIC POSTERIOR CHAMBER IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17712135
• Report Number: 0001313525-2023-70108
• Device Sequence Number: 2226295
• Product Code: MJP
• UDI-Device Identifier: 10757770521392
• UDI-Public: (01)10757770521392(17)251031
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/10/2023

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: 10/31/2025
• Device Model Number: BL1UT
• Device Catalogue Number: BL1UT2550275
• Device Lot Number: 6068707
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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: CI-28 INJECTOR, PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White