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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity: information unknown/not provided.Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2020-(b)(6) 2021.Manufacturer telephone number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to poor vision.There was no vitrectomy, incision enlargement, or sutures required.The surgery was completed successfully using a non-johnson & johnson replacement lens.And the patient is doing good post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review on 8/3/2021, it was determined that hm-visual disturbance- dysphotopsia, 2140 was addressed inappropriately, therefore, this supplemental filing is to correct section h6 with blurry vision.The following section has been updated accordingly: section h6: health effect - clinical code 2137 - blurry vision.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 8/25/2021.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the returned 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 record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.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
• MDR Report Key: 12250477
• Report Number: 9614546-2021-07307
• Device Sequence Number: 3671063
• Product Code: MFK
• UDI-Device Identifier: 05050474560017
• UDI-Public: (01)05050474560017(17)220903
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2021

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: 09/03/2022
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 09/10/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/27/2021; 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 90