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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the za9003 model intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).In a secondary surgical procedure, the iol was explanted due to unknown reasons.Reportedly, the symptoms lasted 28 days.The replacement lens was another jnj iol model zcb00 17.0 diopter iol.It is unknown if the patient was unable to perform any daily activities that they were able to prior to surgery.The iol directions for use were followed.There was no incision enlargement, no suture(s), and no vitrectomy during the lens exchange procedure.It is unknown if medication was prescribed (outside of standard care) or if medical attention was required.Patient status 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.
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, a-5 patient ethnicity, and a-6 patient race: patient information cannot be provided due to personal data privacy legislation/policy.Section section d-6b date explanted: unknown as information was not provided.Section h-3: 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 report will be filed.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: yes.Section d-9: device date returned to manufacturer: 07-jun-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: a lens was received in a j&j lens case.The lens was inspected under magnification.The complaint lens was received cut in half, stuck together, and both haptics were bent.The lens was cleaned and presented with cosmetic damage to the optic body and damage to the edge of the lens.Complaint issues "pt-explant" and "hm-unspecified injury" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 19493482
• Report Number: 3012236936-2024-000161
• Device Sequence Number: 7090102
• Product Code: HQL
• UDI-Device Identifier: 05050474528888
• UDI-Public: (01)05050474528888(17)280404
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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: Prefer Not To Disclose