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

Model Number HEALON DUET PRO

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that during the use of healon a particle/fiber was noticed several times during the procedures.The particle/fiber was in the middle of the substance and was seen inside the patient's eye.No further detail was provided.

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: unknown, as information was requested but not provided section d6a - implant date: not applicable.Healon is not an implantable device.Section d6b - explant date: not applicable.Healon is not an implantable device.Section e1 - telephone number: (b)(6).Section h3 - other (81): the product was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected information: after review of the report we found that inadvertently an incorrect lot number was submitted under report 3012236936-2023-00806 on april 17th, 2023.Therefore, this supplemental filing is to correct that original information.The following field has been updated accordingly: section d4 - model number : healon duet pro, section d4 - catalog number : 10271016, section d4 - lot number : uk31821, section d4 - expiration date : mar 31, 2025, section d4 - unique identifier (udi) number : (b)(4).Section h4 - device manufacture date : nov 8, 2022 , please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information : section b5 - describe event or problem: through follow-up we learned that this occurred twice and that the particle was aspirated from the patients eye without any adverse effect.No further detail was provided.This report is for the first incident reported.A separate report for the second incident reported to us on 19 april will be submitted separately.Corrected data: the section below has been updated in this filing: section b3 - date of event: march 23, 2023 all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON
• Type of Device: 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: 16756316
• MDR Text Key: 313717332
• Report Number: 3012236936-2023-00806
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609723
• UDI-Public: (01)05050474609723(17)250331(10)UK31821
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

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
• Device Operator: Health Professional
• Device Model Number: HEALON DUET PRO
• Device Catalogue Number: 10271016
• Device Lot Number: UK31821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 04/19/2023; 06/29/2023
• Supplement Dates FDA Received: 05/05/2023; 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1