MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL5113

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported event was discarded by the user and it is not available for evaluation.The lot/device manufacturing records were reviewed and found to be acceptable.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A report received from a user facility in the (b)(6) stated that the surgeon had difficulty placing the sleeve on the tip of the phaco handpiece.According to the doctor, the sleeve appears to be more rigid and it doesn't fit that well through a 1.8mm incision.It seems that they do not slide properly through the incision.There was no report of patient injury.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618
• MDR Report Key: 6202178
• MDR Text Key: 63211372
• Report Number: 0001920664-2016-00492
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2017
• Device Model Number: BL5113
• Device Lot Number: V6794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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