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

Model Number BL1UT2400125

Device Problems Device Markings/Labelling Problem (2911); Torn Material (3024)

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

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

Investigation of this complaint is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that two toric lenses that were prepared for surgery did not have axis markers on them.This problem was discovered after the surgeon had made an incision into the patient's eye.As a result of the missing axis markers, the surgery was canceled.This mdr is for lens 1 of 2.

Manufacturer Narrative

Investigation of this complaint is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

Additional information was received and clarified that no issues with the lens axis markers were in fact observed.Instead, it was reported that the haptics of a toric lens sheared off during implantation, resulting in the lens having to be removed from the eye.A second toric lens was then attempted for implantation, but the haptics once again sheared off.This lens also had to be removed from the eye.No incision enlargement or sutures were necessary during the surgery, but the patient was left aphakic at the end of the procedure.The patient then returned four days later and had a different model lens successfully implanted with no issues.This mdr is for lens 1 of 2.

Manufacturer Narrative

The lens was returned for evaluation.Visual inspection found the lens torn in pieces.The optic is complete and has the haptics from one side attached.The haptics from the other side are torn off.The cause of the damage cannot be determined.Functional testing cannot be performed due to the damage.A device history record (dhr) review was performed and did not find any nonconformities or anomalies related to this complaint.Based on the current information, the exact root cause could not be conclusively determined.However, it is likely that user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have 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; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater 33759
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6544047
• MDR Text Key: 74408544
• Report Number: 0001313525-2017-02482
• 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,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: BL1UT2400125
• Device Catalogue Number: BL1UT2400125
• Device Lot Number: 7557520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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