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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor encountered an issue with the injector of a preloaded intraocular lens (iol).There was a problem with loading and delivery of the lens into the patient's eye.The doctor then proceeded using another iol, a 3-piece, model za9003 lens.The lens haptic broke once it was injected into the patient's eye.The lens was then removed from the eye and the patient was left aphakic.The doctor indicated that the patient will need to have a 3-piece lens for sulcus implantation as a replacement lens.No further information was provided.
Additional Manufacturer Narrative
Age or dob, weight, and ethnicity: unknown/ no information provided.If implanted; give date: not applicable.The iol was removed in the initial surgery.If explanted; give date: not applicable as the iol was removed within the same procedure.Initial reporter last name and street address: unknown/ not provided.Email address: unknown/information not provided.Initial reporter telephone number: (b)(6).Health effect: clinical code: (b)(6): this code was used for the reported incomplete treatment.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Date returned to manufacturer: jan 8, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received with a cut to the optic body as well as a detached haptic, which is consistent with a lens that was handled during removal.The lens was cleaned, and haptic damage was observed as well.The complaint issue could be confirmed; however, it may be attributed to handling during removal, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed 2 complaint folders received from this production order.Although the complaint issues reported are related, the issues could not be confirmed as related to manufacturing; therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12785141
• Report Number: 2020664-2021-08024
• Device Sequence Number: 19785277
• Product Code: HQL
• UDI-Device Identifier: 05050474528871
• UDI-Public: (01)05050474528871(17)260115
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 01/15/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030130
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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: Female