MAUDE Adverse Event Report: MOOG INC. ELLIPS FX PHACO HANDPIECE SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, as information was requested but not provided.Section d3 - zip/ postal code (b)(6).Section d6a - implant date: not applicable.Not an implantable device.Section d6b - explant date: not applicable.Not an implantable device; therefore, not explanted.Section e1 - telephone number:(b)(6).Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the handpiece was in the wound for a while and it started to heat up.The doctor decided to withdraw it and replaced the handpiece with a different one.One stitch was administered and the operation was completed.No further information was provided.
Additional Manufacturer Narrative
Corrected information: upon further review, the event is considered to be both a device malfunction and serious injury, since the patient was wounded, requiring sutures to be performed.Section b1 - report type: adverse event.Section h1 - type of reportable event: serious injury.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): MOOG INC.; 2268 south 3270 west; salt lake city UT
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20291976
• Report Number: 3012236936-2024-000244
• Device Sequence Number: 20836203
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132(17)991231(10)E231346
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 690880
• Device Catalogue Number: 690880
• Device Lot Number: E231346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2017
• 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: Required Intervention
• Patient Sex: Unknown