MAUDE Adverse Event Report: BAUSCH + LOMB 25GA COMBINED WIDE-FIELD ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number SE5525WV

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Suture Abrasion (2497)

Event Type  Injury  

Manufacturer Narrative

The manufacturing and sterilization records have been reviewed and are acceptable.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported the trocar leaked during procedure.The surgeon had to suture the incisions which increased surgery duration between 0 to 15 minutes.Patient experienced eye hypotonia.Additional information regarding the event has been requested.

Manufacturer Narrative

Manufacture date h4 revised to (b)(6) 2019 additional event information received that the leak was observed at the end of surgery when the surgeon removed the trocars.The incision was not self-watertight.One incision per trocar thus three sutures were needed.Surgeon sutured incisions and usual ocular pressure was acceptable.Device was not returned for evaluation, we are unable to determine a root cause.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is necessary.

• Brand Name: 25GA COMBINED WIDE-FIELD ELITE PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10356208
• MDR Text Key: 201498904
• Report Number: 0001920664-2020-00090
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: SE5525WV
• Device Catalogue Number: SE5525WV
• Device Lot Number: W5533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention