MAUDE Adverse Event Report: BAUSCH + LOMB INC 25G POSTERIOR ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number SE5425WVB

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The product was discarded on site and could not be recovered.The device history record review was not able to be performed since the lot number is unknown.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action was deemed necessary.No product is available for evaluation, therefore the investigation into the root cause was unable to be performed, and the root cause was determined to be inconclusive.There was no patient impact or injury.The investigation is complete.See related: 0001920664-2021-00011 ¿ first cutter and 0001920664-2021-00013 ¿ third cutter.

Event Description

A user facility reported that in the last month three cutters have failed to cut properly (and that water is leaking side vents of the cutters) during surgery.On these occasions, the user discarded the cutter from the pack and opened an individual cutter to successfully complete the surgery.

• Brand Name: 25G POSTERIOR ELITE W WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB INC; 1400 n goodman st; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st louis, MO 63122 ; 6362263220
• MDR Report Key: 11303528
• MDR Text Key: 244361913
• Report Number: 0001920664-2021-00012
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE5425WVB
• Device Catalogue Number: SE5425WVB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1