MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number	OPO73
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.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 opo73 fusion dual pump pack.A separate mdr report is being submitted for ellips fx phaco handpiece system.No further information provided.
Additional Manufacturer Narrative
Additional narrative information: section h6 coding.Type of investigation: 4112.Investigation findings: 4248.Investigation conclusions: 61.Investigation was completed with no product return as per complaint description, product was discarded and is not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Per complaint description, the issue occurred following the reuse of the opo73 that is designed for single use.Per z311154 rev b, dfu, opo73 (multilingual), "do not re-sterilize, reprocess, or reuse this device".All devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• 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: 15299258
• Report Number: 3012236936-2022-02227
• Device Sequence Number: 7139189
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)250523(10)60370638
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160236
• 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): 10/14/2022

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 Expiration Date: 05/23/2025
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60370638
• 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
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPS FX HANDPIECE, 201360075
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female