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

Model Number	10-2400-16
Medical Device Problem Codes	Mechanical Problem (1384); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threads at the end of the syringe of the ophthalmic viscoelastic device (ovd) did not lock and was just shooting out at the end of the syringe.A brief description of the issue indicated that the cannula was not getting disconnected but would not connect at all.It would spin, there was something wrong with the threads on the syringe.The cannula could not be tightened onto the syringe.There was patient contact; however, there was no patient injury.No further information was provided.This is report 2 of 2 for the second device reported.Another report is being filed for the first device.
Additional Manufacturer Narrative
Sex, weight and ethnicity: asked but unavailable.Implated date: if implanted, give date: not applicable as this is not an implantable device.Explanted date: if explanted, give date: not applicable as this is not an implantable device.The device was not returned for evaluation.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction and additional information: upon further review of the file it was noted that this event is no longer reportable as account indicated that there was no patient contact.Therefore, this supplemental filing is to state that this event is not reportable per additional information received and no further information will be provided under mfr report number 3012236936-2022-01358.The following fields are being corrected in this report: section b5: describe event or problem: additional information received revealed that there was no patient contact.Therefore, the issue is with the thread on the syringe.Section h6: medical device problem code: 2996 (operating system becomes nonfunctional) 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: 14478982
• Report Number: 3012236936-2022-01358
• Device Sequence Number: 5322450
• Product Code: LZP
• UDI-Device Identifier: 05050474651425
• UDI-Public: (01)05050474651425(17)230731(10)UK31064
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 07/31/2023
• Device Model Number: 10-2400-16
• Device Catalogue Number: 10240016
• Device Lot Number: UK31064
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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: Unknown