MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC COMPACT INTUITIV; UNIT, PHACOFRAGMENTATION

Model Number	SCP680300
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue when lowering the bottle to 15 in pole height as he was phasing, stopped the flow of water and caused a cornea burn at the wound on unknown patient's eye.The continue irrigation was on though and no water was flowing when the surgeon noticed.The surgeon turned off continuous irrigation and turned it back on but no irrigation or turning of the mechanisms at the phaco tubing manifold.It was stated he had to end case and reprime and tune.After that it started working.No additional information was provided.
Additional Manufacturer Narrative
A request for patient demographics and patient outcome was requested.However, no additional information was received.Device evaluation: the system was not evaluated by a field service engineer (fse), a clinical specialist or area service manager (asm), personnel were not dispatched to customer site, or no record of a service visit is recorded for this incident.Manufacturing record review: the manufacturing records for the device were reviewed.There were no discrepancies or non-conformance experienced during manufacturing.The system and its components met all specifications prior to being released.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: COMPACT INTUITIV
• 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: 16698047
• Report Number: 3012236936-2023-00831
• Device Sequence Number: 5670800
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133115
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• 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: 03/14/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• 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: Other
• Patient Sex: Unknown