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

Model Number BL1UT

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Visual Impairment (2138)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

The lens was returned for 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 during lens implantation the doctor did not observe axis markings on the lens.The patient's outcome was reportedly the same amount of astigmatism as pre-operation.Subsequently, the lens was exchanged with a different model lens.

Manufacturer Narrative

Mfg date: an at52ao crystalens was returned to b+l inside a trulign lens case (bl1ut 21.00x1.25, sn (b)(4)).After optical testing, the received at52ao is confirmed to be a 14.00 d lens.Three retain samples from lot#7461810 were pulled for evaluation.Lens evaluation did not identify any anomaly with the lenses; axis marks are present and visible.Shipping records indicate that both crystalens at52ao and trulign lenses were shipped to the surgery center.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the current information it cannot be concluded that a lens mix up occurred during manufacturing process, and the root cause of the reported event could not be conclusively determined.

• 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: 5188065
• MDR Text Key: 29836656
• Report Number: 0001313525-2015-02910
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: BL1UT
• Device Lot Number: 7461810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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: 73 YR