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

Model Number	10-2400-16
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: unknown/asked information was not provided.Section a-3a patient sex: unknown/asked information was not provided.Section a-3b patient gender: unknown/asked information was not provided.Section a-4 patient weight: unknown/asked information was not provided.Section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section b-3 date of event: unknown/asked information was not provided.Section d-4 device lot number: unknown as information was not provided.Section d-4 device expiration date: unknown as device lot number was not provided.Section d-4 udi number: the unique device identifier (udi) number is unknown as device lot number was not provided.Section d-6a date implanted: not applicable, as healon is not an implantable device.Section d-6b date explant 74ed: not applicable, as healon is not an implantable device.Section h-3 device evaluated by manufacturer: device lot number is not available; therefore, no further investigation can be performed.The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.If there is any further relevant information received, a supplemental medwatch report will be filed.Section h-4 device manufacture date: unknown, as device lot number was not provided.Efforts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The doctor reported an issue with a new cannula, noting difficulty in passing it through a 1-millimeter side port incision due to its larger size compared to the previous version and an unpolished surface that caused it to catch during use.He observed that in two instances, the cannula released or popped through the incision, with one occurrence involving contact with the capsular bag; however, this did not result in any complications.All cases were completed and no product to return.The doctor stated that while the issue was not critical for him personally, it might pose challenges for his colleagues and inquired about the availability of smoother cannulas if necessary.He also tested the healon pro cannula, which functioned but required additional force and separated into layers during use.No further information is available.

• Brand Name: UNK_OVD_HEALON DUET
• 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: 24880288
• Report Number: 3012236936-2026-000096
• Device Sequence Number: 10495257
• Product Code: LZP
• UDI-Device Identifier: 05050474573574
• UDI-Public: (01)05050474573574(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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 Model Number: 10-2400-16
• Device Catalogue Number: 10290080
• Device Lot Number: UNKNKOWN
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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