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

Model Number	ZA9003
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the za9003 model intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye) but due to poor capsule support the iol would not stay in patient's eye.The iol was removed from the patient's eye and the patient left with no lens in place.There was no patient injury and no medical or surgical intervention was required.Patient status post-procedure is unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed during the initial procedure, therefore not explanted.Section h3-81: 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.Section h-6 health effect - clinical code: 4581 - poor capsule support (eye anatomy issue).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: patient date of birth and gender information was provided with device return.The following fields were updated accordingly: sections a2: patient date of birth: (b)(6) 1961, sections a3: patient gender: male previously reported as no information.Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: 18-dec-2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in a sterilization pouch.The complaint lens was inspected under magnification.The lens was inside a sterilization pouch.The lens was coated in viscoelastic residue and was cleaned.The cleaned lens presented with scratches on the optic body.Complaint issue "positioning issue" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issue could not be confirmed.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: 18221262
• Report Number: 3012236936-2023-03013
• Device Sequence Number: 5602309
• Product Code: HQL
• UDI-Device Identifier: 05050474529045
• UDI-Public: (01)05050474529045(17)240711
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Expiration Date: 07/11/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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: Male