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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4, a5: unknown/asked, but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced, during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced, during the same procedure.Section e1 telephone number (b)(6).Section h3-other (81): the device was not returned for evaluation as it was discarded.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.Attempts have been made to obtain missing information.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
It was reported, that an intraocular lens (iol) had a broken haptic.And the lens was cut out.There was patient contact with the product.Through follow up, it was learned, that when the surgeon put in a lens, the defective haptic broke off inside the eye.Surgeon cut out the lens and tried to put in a secondary lens.However, the lens never came out of the loader.Therefore, a third lens was put in.Surgeon indicated, it was not the best experience overall.The lens has been discarded.No further information was provided.
Additional Manufacturer Narrative
Correction: upon further review of the file, it was discovered that the information previously reported "the surgeon put in a lens, the defective haptic broke off inside the eye.Surgeon cut out the lens and tried to put in a secondary lens, however, the lens never came out of the loader.Therefore a third lens was put in.Surgeon indicated it was not the best experience overall.The lens has been discarded" was inadvertently reported for the wrong file.Therefore, this supplemental report filing is to correct the comments as it is not applicable to this file.Through follow up, it was learned that the customer did not have any further information available.The lens was destroyed.No other information provided.The following section has been updated accordingly: section h6: medical device problem code: 1069 haptic damaged.Section h6: medical device problem codes: 1261 and 3191 previously reported are no longer applicable.All pertinent information available to johnson and 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: 17419041
• Report Number: 3012236936-2023-01929
• Device Sequence Number: 21088977
• Product Code: HQL
• UDI-Device Identifier: 05050474529052
• UDI-Public: (01)05050474529052(17)240123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 01/23/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030220
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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: Unknown