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

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown; requested but not provided.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint history for production order 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 were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from the patient's left eye due to "mechanical failure".There was no patient injury.An incision enlargement was required.No suture or vitrectomy was required.Amvisc viscoelastic was used.Through follow-up, it was clarified that "mechanical failure" meant that the patient was not seeing clearly and described a "strobe-like" light sensation with vision.Another johnson and johnson iol was implanted as replacement (different model, zcb00 +14.5 diopter).The patient's pre-operative uncorrected visual acuity (va) was 20/20 distance vision, 20/60 near vision and best corrected va was 20/20 distance vision and 20/60 near vision.The patient's post-operative (post-initial implant) uncorrected va was 20/20 distance vision, 20/60 near vision and best corrected va 20/20 distance vision and 20/60 near vision.The patient's post-operative (post-replacement implant) uncorrected va was 20/30-2 distance vision and 20/400 near vision and best corrected va not available.The targeted post-operative refraction (for initial implant) was emmetropia, plano sphere.There was no calculation issue.No further information was provided.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 21, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside a plastic bag along with a swab.No other product or components were received.The complaint lens was visually inspected under magnification revealing that the lens was coated in viscoelastic residue.The lens was cleaned and inspected, and no issues that could cause or contribute to the compliant issues were observed.The complaint issue "explant", "visual disturbance- dysphotopsia", and "unexpected postop refraction" were not identified during product evaluation.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 19008900
• Report Number: 3012236936-2024-00978
• Device Sequence Number: 12854066
• Product Code: MFK
• UDI-Device Identifier: 05050474810655
• UDI-Public: (01)05050474810655(17)260505
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/02/2024

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: 05/05/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0145
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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 Sex: Male