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

Model Number	10-2400-16
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that after injection of the healon5 pro a small particle of plastic was observed in the patient's left eye.Issue was notified during implantation or application.It was removed and there was no delay in procedure reported.No medical or surgical interventions reported.It was noted that patient's daily activities were not significantly affected.Patient is fully recovered post-op.No other information was provided.
Additional Manufacturer Narrative
Unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  phone number: +011(514)7810483.The healon 5 pro is not returned for evaluation.Therefore; a failure analysis of the complaint device cannot be completed.A review of the device lot 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON DUET 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: 14123818
• Report Number: 3012236936-2022-01002
• Device Sequence Number: 2427220
• Product Code: LZP
• UDI-Device Identifier: 05050474651425
• UDI-Public: (01)05050474651425(17)220930(10)UJ31037
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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: 09/30/2022
• Device Model Number: 10-2400-16
• Device Catalogue Number: 10240016
• Device Lot Number: UJ31037
• 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: 03/22/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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
• Patient Sex: Male