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

Model Number SE5425WVB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation, so unable to investigate for root cause.The review of the device history records (dhr) for assembly of the finished se5425wb lot w8735 showed the product was properly manufactured, tested, and met all specifications at the time of release.The review of the device history records for the manufacture of the light pipe (part # 102032812) showed that for each of the six lots manufactured and used in lot w8735 (light pipe lots m0034-152, -203, -204, -345, -462, and -463) that the records were acceptable, all functional testing and visual inspection was performed per procedure, no negative quality patterns were reviewed and no non-conformances are associated with the device history records.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.(report 2 of 4 0001920664-2021-00106) see related reports 0001920664-2021-00105, 0001920664-2021-00107, 0001920664-2021-00108).

Event Description

The user facility reported the tip of the light pipe broke after a few seconds of use.The tip did not break in the patient's eye and no sutures were required.The surgery proceeded with a different pack.The surgery was extended by 10 minutes and the anesthesia was prolonged.Aside from the delay in surgery, there was no impact to the patient.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; tree court industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore
• MDR Report Key: 12425477
• MDR Text Key: 270584518
• Report Number: 0001920664-2021-00106
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2021

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: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: SE5425WVB
• Device Catalogue Number: SE5425WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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
• Patient Outcome(s): Required Intervention