MAUDE Adverse Event Report: AMO UPPSALA AB HEALON 5 PRO; AID, SURGICAL, VISCOELASTIC

Model Number	TV60ML
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown; requested but not provided.If implanted, give date: not applicable, the healon5 pro is not an implanted product.If explanted, give date: not applicable, the healon5 pro is not an implanted product.The device is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor was using the cohesive ophthalmic viscosurgical device (ovd) to form the anterior chamber (ac) on a patient post glaucoma shunt.After expressing a significant amount outside the eye, the doctor put some temporally to form the ac followed by nasally.As the doctor was injecting nasally, a minute white particle came out with the healon.It was free floating in the anterior chamber nasally.The doctor depressed the wound to express it out of the eye but was unable to do it without flattening the ac.The doctor was unable to suck it out with the syringe.No further information was provided.Through follow-up it was learned that the patient required a secondary eye surgery for something unrelated to this event, which allowed the doctor to remove the particle from the left eye.There was no patient injury and no planned interventions.The patient is doing well.The product was discarded.No further information was provided.

• Brand Name: HEALON 5 PRO
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14260367
• Report Number: 3012236936-2022-01148
• Device Sequence Number: 5621997
• Product Code: LZP
• UDI-Device Identifier: 05050474636996
• UDI-Public: (01)05050474636996(17)230930(10)UH31463
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• 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): 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: TV60ML
• Device Catalogue Number: 10240015
• Device Lot Number: UH31463
• 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: 04/07/2022
• Initial Report FDA Received Date: 05/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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: BAERVELDT SHUNT
• Patient Sex: Unknown