MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZKU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Iol was explanted in a separate secondary surgical procedure due to complaints of toric intolerance and replaced with a non-johnson & johnson surgical vision lens.There was no medical intervention.Patient outcome post-procedure was reported as fine.Through follow-up, additional information was received clarifying reported toric intolerance as blurry vision and patient was dissatisfied.There were no complications, such as capsular tear, no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), and no unplanned vitrectomy.No further information is available.
Additional Manufacturer Narrative
Additional information: ethnicity: unknown as information was asked but not provided.Date of event: unknown as information was not provided, the best estimate date is between (b)(6) 2021 and (b)(6) 2021.The device was not returned for analysis therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis 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
Product investigation was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 01-dec-2021.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nc/er was found as part of this manufacturing records review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 12841034
• Report Number: 3012236936-2021-00016
• Device Sequence Number: 14541103
• Product Code: HQL
• UDI-Device Identifier: 05050474687011
• UDI-Public: (01)05050474687011(17)250515
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/14/2022

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 Expiration Date: 05/15/2025
• Device Model Number: ZKU150
• Device Catalogue Number: ZKU150U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White