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

Model Number BL1UT

Device Problem Break (1069)

Patient Problem Vitrectomy (2643)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

The device has been returned and is currently under evaluation.Results will be submitted to the fda in a follow-up report.

Event Description

It was reported that the haptic was broken when the lens was implanted in the patient's left eye.The incision was enlarged to remove the lens.Vitrectomy was performed then an anterior chamber lens was implanted.Incision was closed with sutures.

Manufacturer Narrative

The lens was returned to b+l for evaluation.Visual inspection found the lens is in three pieces.The optic has been cut or torn in half.One haptic plate with arms attached has been torn off.The other haptic plate was cut or torn in half with the optic.The device history record was reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the current information, the root cause of the event could not be conclusively determined.However user related factors and/or procedural factors 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; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6960378
• MDR Text Key: 89673311
• Report Number: 0001313525-2017-02817
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: BL1UT
• Device Lot Number: 7372417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• 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