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

Model Number BL1UT2050125

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

The lens has been returned and is currently being evaluated.Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that during lens insertion, the trailing haptic detached from the optic.The leading haptic and optic were inside the eye and the trailing haptic was detached from the lens at the hinge; it stayed in the inserter.The implanted lens and haptic were cut and removed, and a backup lens was implanted with no issue.The physician believes a loading error occurred.The original incision was not enlarged but an additional incision was made for explantation.Protocol sutures were used.The patient's current prognosis is good.

Manufacturer Narrative

Only the haptic plate portion of the lens was returned.Due to the condition in which the lens was returned further testing could not be performed.A retain sample from lot# 7460210 was pulled for dimensional inspection.All dimensional measurements were found to be within specifications.The lot history record was reviewed and there were no non-conformities or anomalies related to this complaint.Based on the current information the exact root cause cannot be determined.However, it is possible that user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

• Brand Name: TRULIGN TORIC POSTERIOR CHAMBER IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 10574 acacia street suite d1; rancho cucamonga CA 91730
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5022788
• MDR Text Key: 23797011
• Report Number: 0001313525-2015-02526
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: BL1UT2050125
• Device Lot Number: 7460210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR