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

Product has been requested for evaluation however it has not been received.Sterilization and lot history records were reviewed and no exceptions were found.Report 2 of 3.

Event Description

Impossible to pass the sleeves into a 2.0 mm incision.

• 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: 6124215
• MDR Text Key: 60763085
• Report Number: 0001920664-2016-00440
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• 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