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

Model Number	TH55ML
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healon pro ovd contained a thread-like particle after being injected into a patient¿s eye.The surgeon successfully removed it using the phaco handpiece and no complications were reported.Additional information suggests that the foreign particle may have been present in the healon or could have resulted from contamination prior to delivery into the eye.It is possible that the hair originated from something in the sterile tray setup.Patient is doing well.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3, a4, a5, a6: unknown/ asked but not available.Section d6a: if implanted, give date: n/a section d6b: if explanted, give date: n/a section h3: other 81: 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: no section d-9: device date returned to manufacturer: no section h-3: device evaluated by manufacturer: yes device evaluation: photos of the suspect product was attached to the complaint file.Photo analysis reveals the lot information of the product.Photo analysis also reveals what appears to be a blurry black mark on a monitor screen.Light reflections and bubbles can also be seen.Due to the quality and resolution of the photo, it cannot be confirmed if the black mark is what customer reported as foreign material.At the time of the investigation, product was not available for evaluation, therefore no testing could be performed.If product is received and product evaluation is required, this investigation record will be reopened to document product evaluation results.Conclusion: the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction.Upon further review it was noticed that section d4: device catalog number was inadvertently reported incorrect.The correct values are as follows: section d4.Device catalog number: 10240016.Primary unique device identification (udi) number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: lot number, manufacturing date, expiration date and udi number are being updated.Upon further review the original reported lot number was incorrect.The correct lot number for the product is up31518.This supplemental is being submitted to address the discrepancy.

• Brand Name: HEALON 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: 20409304
• Report Number: 3012236936-2024-000258
• Device Sequence Number: 12735707
• Product Code: LZP
• UDI-Device Identifier: 05050474651425
• UDI-Public: (01)05050474651425(17)270531(10)UP31438
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2026

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: 10/31/2025
• Device Model Number: TH55ML
• Device Catalogue Number: 10240016
• Device Lot Number: UP31438
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 11/06/2025; 01/07/2026
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/16/2024; 12/03/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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