MAUDE Adverse Event Report: BAUSCH + LOMB 23G FRAGMENTATION NEEDLE, 30 DEG; UNIT, PHACOFRAGMENTATION

Model Number BL5277

Device Problem Break (1069)

Patient Problem Suture Abrasion (2497)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

The device has been requested but has not yet been returned.The investigation is ongoing.

Event Description

The user facility reported the tip of the needle broke off in the patients eye during use.The incision was enlarged and sutures were required.Additional information has been requested.

Manufacturer Narrative

One 23ga needle tip was returned.The original packaging was not returned therefore the part and lot number cannot be determined.Visual inspection found the tip of the needle broken off.Additionally, there is heavy marring, scratches and material missing from around the shaft of the needle above the location of the break.The corners on the hub of the needle are also damaged with rounded corners and marring.The investigation is ongoing.

Manufacturer Narrative

The root cause of the reported event could not be determined due to the condition in which the sample was returned and the uncertainty about how it was used or how many times it may have been used.The vendor investigation concluded the defect did not appear to be due to their manufacturing process.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: 23G FRAGMENTATION NEEDLE, 30 DEG
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9218220
• MDR Text Key: 163168421
• Report Number: 0001920664-2019-00220
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL5277
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• 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: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention