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 Problem Capsular Contracture (1761)

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that capsular fibrosis/striae and anterior lens vaulting were observed.A yag was performed on (b)(6) 2015.Also, patient had astigmatic keratotomy (ak) to correct residual cylinder.This report refers to patient's right eye.According to the surgeon, capsular fibrosis was the likely cause of the event.

Manufacturer Narrative

Relevant pre-op and pre-intervention test results were received.

Manufacturer Narrative

The lot number of the device was not provided, and the device was not returned to the manufacturer for evaluation.Therefore, a device history review (dhr) and product evaluation could not be conducted.Based on the information provided, the exact root cause of the event cannot 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: 5164107
• MDR Text Key: 28796241
• Report Number: 0001313525-2015-02891
• 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,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL1UT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR