MAUDE Adverse Event Report: CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.) INTRALASE FLAP LIFTER DOUBLE ENDED; OPTHALMIC SPATULA

Catalog Number	K3-2538
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Visual Disturbances (2140); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The received instruments will be sent to vendor for complete evaluation and root cause investigation.Initial assessment shows no flaking or chipping on the surface of all 6 instruments.Additional information and specific details of the incident including current patient status was requested from the reporter.No response from the reporter at this time.Follow up information and clarification from the reporter including investigation results will be submitted when available.
Event or Problem Description
On 26-dec-2023, a distributor from france informed corza medical customer service representative that they received a complaint from their customer against k3-2538 intralase flap lifter double.The distributor stated that on (b)(6) 2022, the customer purchased 6 manipulators.These manipulators are used by a single doctor who performs multiple procedures once a month.Over several months, the surgeon noticed metal deposits in the postoperative interface.The dates of these procedures were on (b)(6) 2023.There are multiple instruments involved during the procedures including a non-katena micromanipulator and a blepharostat.The doctor stated that one patient experienced visual discomfort and photic effects.The 6 katena k3-2538 instruments were removed from future procedures and sent to katena for evaluation.On 22-jan-2023 katena (corza opthalmology) received the instruments.
Additional Manufacturer Narrative
On 29-feb-2024, the vendor (mmi) returned the instruments to katena products inc.With investigation conclusions.The reported issue that the katena instruments produced metal deposits during procedure is not confirmed.The manufacturing team inspected all 6 of the instruments and they concluded that there are no defects on the instruments (k3-2538) that would cause debris while using the instrument.
Event or Problem Description
This report is a follow up to 2242450-2024-00001 which was submitted on 24-jan-2024.The complaint samples (b)(4) were returned to the manufacturing vendor for investigation.On 29-feb-2024, the vendor provided the results of their investigation.

• Brand Name: INTRALASE FLAP LIFTER DOUBLE ENDED
• Common Device Name: OPTHALMIC SPATULA
• Manufacturer (Section D): CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.); 6 campus drive, suite 310; parsippany NJ 07054
• Manufacturer (Section G): CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.); 6 campus drive, suite 310; parsippany NJ 07054
• Manufacturer Contact: bryan weinmann ; 6 campus drive suite 310; parsippany, NJ 07054 ; 9739573509
• MDR Report Key: 18576893
• Report Number: 2242450-2024-00001
• Device Sequence Number: 21061474
• Product Code: HND
• UDI-Device Identifier: 00841668103210
• UDI-Public: 00841668103210
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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 Catalogue Number: K3-2538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown