MAUDE Adverse Event Report: BAUSCH + LOMB SILICONE COATED I/A 45 HANDHELD INSTRUMENT; UNIT, PHACOFRAGMENTATION

Model Number 85910ST

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Capsular Bag Tear (2639)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

The device history was reviewed, no deviation or issue detected.Lot was manufactured according to specifications.The product was not available for evaluation.Further investigation is underway.

Event Description

The user facility reported the metal tip of the handpiece slipped out of the silicone sleeve after the cortex was removed, and the patient sustained a capsular tear.The toric lens was still placed as intended.The customer did not provide information as to how the tear was repaired.

Manufacturer Narrative

The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is complete.No corrective action is necessary at this time.

• Brand Name: SILICONE COATED I/A 45 HANDHELD INSTRUMENT
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman; rochester NY 14609
• MDR Report Key: 8002701
• MDR Text Key: 124946113
• Report Number: 0001920664-2018-00149
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K073023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 85910ST
• Device Catalogue Number: 85910ST
• Device Lot Number: FS10864486
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other