MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZA9003
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: information cannot be provided due to personal data privacy legislation/policy.Section a-3a patient sex: information cannot be provided due to personal data privacy legislation/policy.Section a-3b patient gender: information cannot be provided due to personal data privacy legislation/policy.Section a-4 patient weight: information cannot be provided due to personal data privacy legislation/policy.Section a-5 patient ethnicity: information cannot be provided due to personal data privacy legislation/policy.Section a-6 patient race: information cannot be provided due to personal data privacy legislation/policy.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Section h-6 health effect - clinical code: 4581 device decentered all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The za9003 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).During a consult appointment, it was reported the iol was subluxed/displaced, thus the iol was explanted in a secondary surgical procedure and replaced with a ar40e 11.0 iol.There were no sutures during the lens exchange procedure however, a vitrectomy was performed.The iol directions for use were followed.Patient prognosis post lens exchange was reported as fully recovered.Patient information cannot be provided due to personal data privacy legislation/policy.No further information is available.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 22538442
• Report Number: 3012236936-2025-000197
• Device Sequence Number: 20837429
• Product Code: HQL
• UDI-Device Identifier: 05050474528857
• UDI-Public: (01)05050474528857
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030120
• 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: 07/01/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown