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

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

As surgeon was applying viscoelastic the cannula reportedly popped off.When the surgeon inspected the device, the viscoelastic syringe did not have the threaded collar according to the report.There was no injury to the patient.

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation.Therefore a product evaluation could not be conducted.A device history record (dhr) could not be performed as the lot number for the device was not provided.Based on the information available, the root cause of the reported event could not be conclusively determined.

• Brand Name: OCUCOAT VISCOELASTIC
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7023301
• MDR Text Key: 92646309
• Report Number: 0001313525-2017-02834
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• 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