MAUDE Adverse Event Report: BAUSCH + LOMB OCUCOAT VISCOELASTIC; AID, SURGICAL, VISCOELASTIC

Lot Number 026637

Device Problem Contamination (1120)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 08/08/2017

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 the surgeon observed fibers on the posterior surface of the lens after implanting into the eye.The surgeon first tried removing them with the irrigation/aspiration handpiece.The remaining fibers were then attempted to be removed with the capsulorhexis forceps, but the capsular bag was punctured in the process.An anterior vitrectomy had to be carried out as a result.Additional event information has been requested but has not been received.

Manufacturer Narrative

The viscoelastic was returned to b+l for evaluation.Microscopic examination of the solution, tip, and exterior of the components found no fibers.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information, a root cause could not be identified.

• Brand Name: OCUCOAT VISCOELASTIC
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6847433
• MDR Text Key: 85080946
• Report Number: 0001313525-2017-02752
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Lot Number: 026637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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