MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: after the surgery, field service engineer visited the hospital and checked the equipment left as they were of the surgery.He was unable to reproduce the reported event, and there was no issue with irrigation, and phaco tip and sleeve were fitted without any problem.There was no error log in system.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient felt heat while surgeon was sculpting a groove in a nucleus with ellips fx handpiece.Surgeon immediately took the tip off from the patient's eye.The incision in patient's eye received mild thermal burn.The surgeon checked the handpiece and confirmed the handpiece had become hot.Surgeon replaced with the phaco machine and equipment of another company¿s product, and the surgery was successfully completed.Surgeon used the us power 85% setting and fully applied the foot pedal when the issue occurred.Opo73 fusion dual pump pack was used for multiple procedures prior to the incident.Opo73 was discarded by the customer and no sample was going to be returned for investigation.There was no vitrectomy performed, no medication for thermal burn treatment was reportedly provided.Sutures were used to prevent further patient injury.The incision size was reported as 2.4mm.This report is for ellips fx phaco handpiece system.A separate mdr report is being submitted for opo73 fusion dual pump pack.No further information provided.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15303348
• Report Number: 3012236936-2022-02226
• Device Sequence Number: 15074118
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132(17)991231(10)E225415
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: E225415
• 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: 07/28/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 201360075, OPO73
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female