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

Model Number BL1UT

Device Problem Positioning Problem (3009)

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

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

The lens has been returned to b+l and is currently under evaluation.Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the lens was implanted and removed as it could not position properly in the patient's eye.Reportedly the lens could not be rotated as the haptics were not in capsule.The incision was enlarged but it is unknown if any sutures were required.A back up lens was implanted with no issues.The patient's current status is good, patient is doing well.

Manufacturer Narrative

The lens was returned to b+l.Visual inspection found portion of the optic and trailing haptic plate missing.Due to the condition in which the lens was returned further testing could not be performed.One retain sample from the same lot (025092) was dimensionally inspected and all measurements were found to be within specifications.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the information available, the root cause of the reported event could not be determined.However, it is possible that user-related factors (such as surgical technique) caused or 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: 5190016
• MDR Text Key: 29912871
• Report Number: 0001313525-2015-02916
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2018
• Device Model Number: BL1UT
• Device Lot Number: 025092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• 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: 61 YR