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

Model Number	ZKB00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye because of opacification on the lens.The patient could not see clearly, and their vision was blurry.The lens was cut in 3 pieces to leave central zone with opacity intact.Another johnson and johnson lens with the same model and diopter implanted as a replacement.It was confirmed that the problem was not a pre-existing issue, it was not posterior capsular opacification (pco), and no yttrium-aluminum-garnet (yag) was performed.The patient is doing fine post explant and no injury was reported, and the patient outcome was good.No other information was provided.
Additional Manufacturer Narrative
Date of event: the exact date of event is unknown, not provided, but it was stated that the symptoms started immediately after implantation on (b)(6) 2022.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Attempts were made to obtain the missing information; however, the information has not been provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information/corrected data: additional information received from the doctor indicated that the date of explant was (b)(6) 2022 and not (b)(6) 2022 that initially reported and captured in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the following field was updated accordingly: section d6b: if explanted, give date: (b)(6) 2022.Section d9: device available for evaluation: yes, section d9: returned to manufacturer on: nov 7, 2022, section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received for evaluation.Visual inspection under magnification was performed and the lens was observed to be cut into 3 pieces with scratches on the optic body.The lens was cleaned and further inspected under magnification and a cloudy substance that could not be cleaned was identified on the lens.However, based on the haze test results, there were no issues that could be related to inclusions during the manufacturing process.The complaint issue ¿inclusions¿ was not confirmed.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15705289
• Report Number: 3012236936-2022-02721
• Device Sequence Number: 14716851
• Product Code: MFK
• UDI-Device Identifier: 05050474560079
• UDI-Public: (01)05050474560079(17)251221
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 12/21/2025
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0195
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE. LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White