MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cataract surgery, there was corneal wound burn experienced that required 5 stitches.Surgeon stated that there was clog but continued to phaco.No further information provided.
Additional Manufacturer Narrative
Additional narrative information: age at time of event: unknown.Date of birth and gender: unknown.Patient weight: unknown.Ethnicity and race: unknown.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: a review of the device history record (dhr) showed that there were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.A review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews was performed.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13653047
• Report Number: 3012236936-2022-00522
• Device Sequence Number: 12207521
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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
• 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: 02/01/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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: SN: (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown