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

Model Number BL1UT

Device Problem Insufficient Information (3190)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

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 patient was not satisfied with her visual outcome approximately 20 days post successful lens implant.Reportedly, the lens/eye was not accommodating properly.The patient went to another ophthalmologist for a third opinion.The third opinion doctor agreed that the surgery looked fine and that the patient should get eventually used to her iol.The third opinion doctor didn't feel that lens explant was a good idea since patient's vision was "close to perfect both eyes".The patient tested 20/25 and j4 ou, with astigmatism.The lens was explanted approximately 12 months post lens implant and another model lens was implanted.The surgeon indicated that in his opinion the likely cause of the events was significant ciliary muscle function.The patient's current status was described as "good".This event pertains to the patient's left eye.

Manufacturer Narrative

The lens was not returned to the manufacturer for evaluation.One retain sample from the same lot (025020) was 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.

• 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: 5308875
• MDR Text Key: 33833933
• Report Number: 0001313525-2015-03033
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2015

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: 025020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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: 67 YR