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

Model Number BL1UT

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after insertion of the iol a tear was noticed in the lens.The lens was then removed and replaced with same model and diopter power.Sutures that were not part of the standard protocol were required.Patient prognosis is "post-op cataract care with physician".

Manufacturer Narrative

Additional info.The device was returned for evaluation.Visual inspection found the lens in three pieces.The optic had been cut or torn in half.One plate was torn off and was lying loose in the carrier.Both haptic arms on the torn off plate were bent.The other plate was attached to the optic but the haptic arms were bent.A device history record (dhr) review did not find any non-conformities or anomalies related to this complaint.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have contributed to the event.

• Brand Name: TRULIGN TORIC POSTERIOR CHAMBER IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH AND LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 9170125
• MDR Text Key: 161719221
• Report Number: 0001313525-2019-00154
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/09/2019

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: 03/31/2021
• Device Model Number: BL1UT
• Device Catalogue Number: BL1UT2250125
• Device Lot Number: 7645406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CRYSTALSERT INSERTER; CRYSTALSERT INSERTER
• Patient Outcome(s): Other