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

Model Number	E2798
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
The device has been requested but not yet received.This investigation is ongoing.
Additional 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
• Common Device Name: 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
• Report Number: 0001920664-2023-70046
• Device Sequence Number: 20198837
• Product Code: HNJ
• UDI-Device Identifier: 00757770416363
• UDI-Public: (01)00757770416363
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: E2798
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown