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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity and race: unknown as information was not provided.Date explanted: not applicable as the iol remains implanted in the patient's ocular sinister (left eye).(b)(4).It was indicated that the iol is not being returned for evaluation as it remains implanted.Therefore, a failure 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.
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye).Patient reports complaints of double vision starting approximately 2 to 3 years ago but did not have the issues checked earlier by a doctor due to the covid pandemic.When asked if symptoms are debilitating, patient stated can't read the paper, can't take walks, and can't drive as it is not safe.Double vision occurs when both eyes are open.If he closes either eye the double vision goes away.Patient does not have diabetes but takes atenolol to regulate high blood pressure.He is scheduled to see a specialist in early september.Patient was informed that the iol model and serial number he has implanted was not involved in a product recall.No further information provided.

• 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: 12368214
• Report Number: 9614546-2021-07321
• Device Sequence Number: 11737820
• Product Code: MFK
• UDI-Device Identifier: 05050474535640
• UDI-Public: (01)05050474535640(17)131219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 12/19/2013
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: Other
• Patient Age: 75 YR