MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT, PHACOFRAGMENTATION

Model Number BL5113

Device Problem Particulates (1451)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported that during cataract procedure, a fragment of the tightening tool of the handpiece needle went into the patient¿s eye.When the needle placed on the phaco device was inserted into the patient's eye the surgeon noticed a ''small piece of plastic." the particulate was seen under the microscope and was removed using surgical pliers.The surgery time was not significantly increased.No patient injury reported.

Manufacturer Narrative

The particle was not returned for analysis.One small plastic vial was returned with a needle wrench inside.The original packaging was not returned.The part number and lot number cannot be verified or determined.The rest of the pack assembly was not returned.Visual inspection found the needle wrench flats are damaged and deformed with marring and gouges.Material is missing and some of the damaged areas are sticking up around the edges.Although, the cause of the damage to the needle wrench cannot be determined; it is indicative of over-torquing while tightening the needle.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action required.

• Brand Name: STELLARIS MICRO INCISION VACUUM PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9830036
• MDR Text Key: 183539493
• Report Number: 0001920664-2020-00045
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: BL5113
• Device Catalogue Number: BL5113
• Device Lot Number: W4632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1