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

Model Number	TH85ML
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an unknown number of events, on unknown dates, of 'brown hair' in patient's eyes when applying healon pro.No further information is available.
Additional 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 d4 - catalog number: a complete number is unknown, as product lot number was not provided.Section d4 - expiration date: unknown, as product lot number was not provided.Section d4 - lot number: unknown/not provided section d4 - udi number: unknown, as product lot number was 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 healon pro 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.Section h4.Device manufacture date: unknown, as the lot number of the device was not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: UNK_OVD_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: 18754453
• Report Number: 3012236936-2024-00345
• Device Sequence Number: 3837632
• Product Code: LZP
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 02/21/2024

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 Model Number: TH85ML
• Device Catalogue Number: UNK-OVD_HEALON PRO
• Device Lot Number: UNKNOWN
• 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: 01/30/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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