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 Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that significant attempts were made over the past two years to improve the patient¿s ocular surface (dry eyes) via prescription eyedrops and ipl/lipiflow combination, and several amniotic membrane placements.Also, a yag (yttrium aluminum garnet) capsulotomy was performed on both eyes (ou) and a lasik procedure in the left eye (os) only was performed to treat minimal refractive error.None of these measures proved successful in alleviating the patient¿s complaints as they are related to poor visual quality and glare, particularly of his left eye.After careful evaluation, customer pursued suspect lens explant procedure to achieve symptom relief.So finally, an exchange was performed to remove lens form the patient's left eye due to poor subjective vision quality at all distances despite refractive touch up and yag capsulotomy.A 3-piece, 23.0 diopter size non-johnson and johnson lens was implanted in the sulcus with optic capture.At the time of the explant procedure incision enlargement was done (simply to accommodate the 3pc iol cartridge) and a single suture for the primary incision.The patient outcome, post-op day-1 visual acuity 20/40 ph 20/30 doing well with typical postoperative edema.There was no patient post-explant injury.The explanted lens was bisected and discarded.No other information was provided.
Additional Manufacturer Narrative
(patient weight) and (ethnicity): asku/ not provided.The intraocular lens (iol) is not returning for evaluation as it was discarded; 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.(b)(4).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: 15299259
• Report Number: 3012236936-2022-02270
• Device Sequence Number: 15238588
• Product Code: MFK
• UDI-Device Identifier: 05050474560741
• UDI-Public: (01)05050474560741(17)220926
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 09/26/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0235
• Was Device Available for Evaluation?: No
• 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: 08/01/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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 Sex: Male
• Patient Race: White