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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was unhappy with the intraocular lens (iol) implanted into patient's right eye and was complaining of hazy vision.Additional information received revealed that the lens was explanted and another competitor lens of +12.0 diopter was used as the replacement.The pre-operative visual acuity was 20/80 and visual acuity post implantation with the original lens was 20/40.No other medical/ surgical intervention performed.The patient was still recovering from the explant surgery.No other information was provided.
Additional Manufacturer Narrative
Date of event: best estimate is between (b)(6) 2022 and (b)(6) 2022.The intraocular lens (iol) 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 was made to obtain additional information regarding the event; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the date of event which the patient¿s symptoms first were noticed was 10/25/22.Therefore, the following field was updated accordingly: section b3: date of event: 10/25/2022.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: dec 19, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in a white plastic cap, covered with masking tape.A label with patient information was also received.Visual inspection under magnification revealed that the lens was received cut in half and coated in viscoelastic residue.The lens was cleaned and inspected under magnification and no issues that could cause or contribute to the complaint issue were identified.The complaint issues were not confirmed.The other observed issue 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.Corrected data: based on the additional information received with the returned device, it was noted that the initial information populated in the sections "a2 and d6b" of the initial mdr were inadvertently incorrect.Therefore, the information has been corrected in this supplemental mdr report and the following fields were corrected as indicated below: section a2.Date of birth/age: on (b)(6) 1963 / 59 yrs.Section d6b.If explanted, give date: on (b)(6) 2022.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: 15988749
• Report Number: 3012236936-2022-03052
• Device Sequence Number: 14870957
• Product Code: MFK
• UDI-Device Identifier: 05050474560574
• UDI-Public: (01)05050474560574(17)221016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/07/2023

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: 10/16/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0150
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 01/12/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 12/27/2022; 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2018
• 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: 59 YR
• Patient Sex: Female
• Patient Race: Asian