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

Model Number BL1UT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Visual Impairment (2138); Fibrosis (3167)

Event Date 11/28/2017

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 a patient experienced a lens positioning change in the left eye four months post-cataract surgery.Regarding pre-existing ocular conditions, it was noted that the patient had previously undergone radial keratotomy (rk) surgery.During the cataract surgery, the surgeon had to use two 10-0 sutures to close the wound due to the previous rk surgery cuts.One of the sutures was radial and the other was circumferential so as to close the gap between the rk surgery incisions.It was specified that the implanted lens vaulted in the posterior direction.In addition, one of the lens platforms came out of the capsular bag in the anterior direction, forming an "l" shape.The lens platform that remained in the capsular bag became "fibrosed," though the haptics remained free.The patient had also noticed a decrease in their vision.A lens exchange was performed twelve days after onset.The patient is expected to return to the clinic for ongoing evaluation and care.

Manufacturer Narrative

The lens was not returned for evaluation.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information, the root cause of the reported could not be determined.

• Brand Name: TRULIGN TORIC POSTERIOR CHAMBER IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; 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: 7162871
• MDR Text Key: 96319753
• Report Number: 0001313525-2018-00006
• 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: 12/08/2017

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: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: BL1UT
• Device Catalogue Number: BL1UT2150275
• Device Lot Number: 7558009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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
• Patient Age: 70 YR