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

Model Number 10-2900-80

Device Problem Contamination (1120)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported during the procedure a small translucent fiber was discovered in the healon endocoat; the doctor was able to retrieve it.The case was completed with no patient harm.Additional information was received confirming the foreign material was in the patient's ocular sinister (left eye).Patient outcome post-procedure was reported as unaffected.No further information is available.

Manufacturer Narrative

Patient weight, and ethnicity and race: unknown as information was asked but not provided.Date implanted: not applicable, as healon is not an implantable device.Date explanted: not applicable, as healon is not an implantable device.Hence, not explanted.The device was not returned for analysis therefore, a visual 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.Attempts have been made to obtain missing information; however, to date, no information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Product investigation was completed, and the following fields were updated accordingly: section h-3: device evaluated by manufacturer: yes batch record review: final product testing for particulates meets the product specifications.Complaint history review: this is the first complaint for lot# 029469.There is no similar particulate complaints for sibling healon lot# 029468.Complaint review over a one year period from the aware date indicates there has been one similar complaint with a healon endocoat product for particulates.There have been no trends identified for particulates within solution for all lifecore manufactured syringe products.Evaluation of returned product: no product was returned and no photos were provided.The complaint indication could not be visually confirmed.Archive review: an archive review of (b)(4) units was performed.Inspection of (b)(4) retained syringes did not identify any additional particles.Therefore, the batch is considered essentially free of visible particles.Conclusion: no lifecore manufacturing root cause was identified.Occurrence rating for visual particulates are in line with expected rates per (b)(6) (13) fmea: 3% nahy manufacturing process.The review indicates this lot was manufactured per procedure and meets the product specifications.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON DUET
• 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: 13565421
• MDR Text Key: 287696007
• Report Number: 3012236936-2022-00430
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)230531(10)029469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 10-2900-80
• Device Catalogue Number: 57502000
• Device Lot Number: 029469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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
• Patient Sex: Female