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

Model Number	DFW300
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137); Halo (2227)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: information unknown/not provided.Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2022.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, 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.An attempt has been made to obtain missing information; however, no definitive response has been received.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 left eye due to a mechanical failure.The incision was enlarged to remove the lens in whole, however, sutures and a vitrectomy were not required.There was no patient injury.No other information was provided.
Additional Manufacturer Narrative
Additional info: additional information was provided that the mechanical failure of implant was due to visual symptoms.The patient reported constant blurred vision at distance and near and constant halos affecting driving.Another johnson & johnson lens, model zcu225 10.5 diopter was successfully implanted as a replacement.The patient was stable post-operatively.The date of event was provided.No other information was provided.The following sections have been updated accordingly: section b3: date of event: (b)(6) 2022.Section h6: health effect - clinical code: 2227 halo.Section h6: health effect - clinical code: 2137 blurry.The code provided in the initial report 1845 - eye injury is no longer applicable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: jan 12, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the suspect lens was received wrapped in medical gauze.Visual inspection under magnification revealed that the lens was coated in blood.The lens was cleaned and further inspected under magnification, and no issues were identified.No issues that could cause or contribute to the complaint issues were observed.The complaint issues were not confirmed; therefore, there is no indication of a product deficiency or product malfunction.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.
Additional Manufacturer Narrative
Correction: upon further review, it was noted that the supplemental mdr inadvertently did not include h6: medical device problem code: 2993 no reported device problem.Therefore, it is updated in this mdr.H6:medical device problem code: 1384 - mechanical problem was no longer applicable.The following section has been updated accordingly: h6: medical device problem code: 2993 no reported device problem.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: 15993159
• Report Number: 3012236936-2022-03124
• Device Sequence Number: 6089730
• Product Code: MFK
• UDI-Device Identifier: 05050474752276
• UDI-Public: (01)05050474752276(17)240331
• 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: 2022
• Device Explanted Year: 2022
• 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,Followup,Followup
• Report Date (Section B): 01/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: DFW300
• Device Catalogue Number: DFW300U115
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 01/13/2023; 01/24/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/10/2023; 01/20/2023; 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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: AMVISC VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male