MAUDE Adverse Event Report: BAUSCH + LOMB PUNCH DECEMET MEMBRANE KELLY; PUNCH, CORNEO-SCLERAL

Model Number E2798

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/05/2023

Event Type  Injury  

Event Description

The user facility reported that during procedure to treat glaucoma, the tip of the storz kelly decement membrane punch broke and got lodged in the patient¿s left eye.The patient had the broken piece removed from the eye by a retina specialist the same day at another facility.There was no enlargement from the secondary surgery, and it is unknown if the patient had anesthesia at another facility.The current status of the patient was reported as stable and is home recovering.

Manufacturer Narrative

The device has been requested but not yet received.This investigation is ongoing.

Manufacturer Narrative

The device was not returned for evaluation, therefore a root cause into the complaint could not be established.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: PUNCH DECEMET MEMBRANE KELLY
• Type of Device: PUNCH, CORNEO-SCLERAL
• Manufacturer (Section D): BAUSCH + LOMB; 3365 treecourt industrial blvd; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16865951
• MDR Text Key: 314524522
• Report Number: 0001920664-2023-70046
• Device Sequence Number: 1
• Product Code: HNJ
• UDI-Device Identifier: 00757770416363
• UDI-Public: (01)00757770416363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2798
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR