MAUDE Adverse Event Report: BAUSCH + LOMB, INC 25G POSTERIOR X PACK WITH V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number BL5425WVX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Endophthalmitis (1835)

Event Date 08/10/2022

Event Type  Injury  

Event Description

A user facility in japan reported that three cases of post-op endophthalmitis on three patients.A pack was discontinued in japan, and the surgeon switched to a different part number.After the switch to this pack, they noticed that two cases happened.The surgeon put an additional filter into the pressurization route as the perfusion process changed from spontaneous drip to pressurized perfusion with the new pack.Bss was also changed from a soft pack product to a glass bottle product.At the time, the surgeon considered that the issue was not caused by the disposable pack, and thought the bss was the cause.Patients are in remission after being given typical eyedrops, and are no longer under treatment.There was no decreased visual acuity, and no hospitalization was required.This report is on the first case only.

Manufacturer Narrative

The device was discarded by the user.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.See related 0001920664-2022-00116 and 0001920664-2022-00125.

Manufacturer Narrative

The product was discarded and is reported as not available.Unable to investigate further for root cause which is unknown.A review of the monthly bioburden results for the six months surrounding the manufacture of this product on 12-10-2021 shows all bioburden values were within acceptable parameters.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.The investigation is complete.See related 0001920664-2022-00116 and 0001920664-2022-00125.

• Brand Name: 25G POSTERIOR X PACK WITH V&AFI&WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 636226-322
• MDR Report Key: 15374823
• MDR Text Key: 299448400
• Report Number: 0001920664-2022-00124
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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: 05/01/2023
• Device Model Number: BL5425WVX
• Device Lot Number: X0768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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
• Treatment: BSS
• Patient Outcome(s): Other