MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMBINED WIDE-FIELD ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number SE5523WV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Suture Abrasion (2497)

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The user facility in the (b)(6) reported that the wound is leaking more than expected after removing the trocar from the port, leading to suturing the incision.

Manufacturer Narrative

A review of the non-conformance(nc) database did not show any ncs for se5523w that would have contributed to this complaint.The 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: 23GA COMBINED WIDE-FIELD ELITE PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman; rochester NY 14609
• MDR Report Key: 8650339
• MDR Text Key: 146381017
• Report Number: 0001920664-2019-00099
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SE5523WV
• Device Catalogue Number: SE5523WV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1