MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	MX60ET
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated.Microscopic examination found the lens cut in 2 pieces across the optic.The iol haptics did not exhibit any defects or breakage in the junction area.A device history record (dhr) review did not find any non-conformities or anomalies related to this event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the information provided a root cause could not be established.
Event or Problem Description
It was reported that after the insertion of an iol, into the eye, a portion of the iol haptic/optic junction was broken.The surgeon made the decision to leave the iol in the eye, because it seemed stable.Approximately a week after the implantation, there was a forty-degree rotation of the iol.The iol was explanted and replaced with a lens of the same model and diopter, 2 weeks post-implantation.In the surgeon''s opinion, the partially broken optic/haptic junction may have caused the iol rotation.The patient outcome is good.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 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: 18584208
• Report Number: 0001313525-2024-70006
• Device Sequence Number: 7077000
• Product Code: MJP
• UDI-Device Identifier: 10757770557131
• UDI-Public: (01)10757770557131(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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: 02/28/2026
• Device Model Number: MX60ET
• Device Catalogue Number: MXUET425+190
• Device Lot Number: 32306613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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: BLIS-X1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown