MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE SYSTEM; PHACO MACHINE

Model Number	NGP680300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Burn (2523); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: unknown/ not provided.Date of birth and gender: unknown/ not provided.Patient weight: unknown/ not provided.Ethnicity and race: unknown/ not provided.Date of event: date unknown/ not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that surgeon had a patient who had very dense lense and probably during sculpt he achieved a thermal injury to the cornea requiring him to have to suture the cornea at the end of the cases.Reportedly patient was doing fine, but at day 1 he decided to leave in sutures until the 1-week post op visit.Additional information was received, and it was learnt that surgeon decided to leave the sutures for little longer.No further information was provided.This report captures information for one patient.Another report is being submitted to capture information for a second patient that experienced similar event.
Additional Manufacturer Narrative
Date of event: date unknown/ not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that surgeon had a patient who had very dense lense and probably during sculpt he achieved a thermal injury to the cornea requiring him to have to suture the cornea at the end of the cases.Reportedly patient was doing fine, but at day 1 he decided to leave in sutures until the 1-week post op visit.Additional information was received, and it was learnt that surgeon decided to leave the sutures for little longer.No further information was provided.This report captures information for one patient.Another report is being submitted to capture information for a second patient that experienced similar event.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Common Device Name: PHACO MACHINE
• 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: 13579399
• Report Number: 3012236936-2022-00465
• Device Sequence Number: 19936004
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• 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): 02/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• 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: 01/26/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2010
• 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