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

Model Number BL1UT

Device Problem Material Integrity Problem (2978)

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

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the lens was removed intraoperatively from the patient''s right eye due to unspecified lens damaged noted during insertion.The incision was enlarged to remove the lens and a back-up lens was implanted successfully.The patient''s prognosis was reported as " patient doing very well without problems".

Manufacturer Narrative

Visual inspection of the retuned lens found the plate damaged (tears and damaged haptic).Further testing could not be performed due to the condition of the returned lens.One retain sample from the same lot (7546117) was dimensionally inspected and all measurements were within specification.The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the information available, the exact cause of the reported event could not be conclusively 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; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 10574 acacia street suite d1; rancho cucamonga CA 91730
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5459092
• MDR Text Key: 38961304
• Report Number: 0001313525-2016-00056
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: BL1UT
• Device Lot Number: 7546117022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: No
• 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: 74 YR