MAUDE Adverse Event Report: BAUSCH + LOMB, INC UNIVERSAL VISCOUS FLUID CONTROL PACK; TUBING, REPLACEMENT, PHACOFRAGMENTATION UNIT

Model Number BL7600

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The lot history for this product shows no issues related to the reported complaint.The cannula was returned in an opened pouch.The detached piece of cannula core was returned in a plastic container, sealed with a surgical glove.The detached core element is entirely cylindrical.The intact portion ends in a taper.Separation occurred at the junction of taper and small outer diameter section of the cannula core.The edges at separation are rough as having been torn.The cannula does not appear to have been struck or pinched as openings of both pieces remain round.A small curl in edge of detached cylindrical portion may be an indication of the cannula having been bent.A mechanical force could cause a portion of the device to break.Not enough information is available to determine a definite root cause, however the probable root cause is a mechanical issue.The review of the lot history, trend analysis, risk analysis and/or directions for use were considered acceptable, with the product performing within anticipated rates.No corrective action was deemed necessary.The patient is doing well.There is no report of a visual problem.The investigation is complete.

Event Description

A user facility reported that during oil injection the tip of the 23g vfi cannula fell off and into the back of the eye and caused suprachoroidal hemorrhage.The cannula was flushed/removed.The bleeding was removed with the irrigation/aspiration handpiece.There was no further action required.

• Brand Name: UNIVERSAL VISCOUS FLUID CONTROL PACK
• Type of Device: TUBING, REPLACEMENT, PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• MDR Report Key: 11658569
• MDR Text Key: 280544201
• Report Number: 0001932402-2021-00002
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): Y
• PMA/PMN Number: K121675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: BL7600
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1