MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, but the best estimate date is between 12/18/2018 and 7/17/2020.Section h3-other (81): 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 have been made to obtain missing information; however, to date, no 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 the extended range of vision non preloaded intraocular lens (iol) was explanted from the patient's left eye.The lens was replaced with lens model zxr00 19.0 diopter.No further information is available.
Additional Manufacturer Narrative
Correction: based on the additional information and further review, the original lens was identified as zkb00 (sn: (b)(6).The following information was added to reflect the new information: section b5: it was reported that the non preloaded multifocal intraocular lens (iol) was explanted from the patient's left eye with an unknown reason for explant.The lens was explanted and replaced with lens model zcb00 15.5 diopter.No further information is available.Section d1: brand name: tecnis iol.Section d2: common device name: lens, multifocal intraocular; device product code: mfk.Section d3:establishment name: amo manufacturing netherlands, email address::snagpal3@its.Jnj.Com, country:netherlands.City:groningen, state, province or territory:groningen, postal office or zip code:9728 nx section d4: model number: zkb00.Section d4: catalog number: zkb00u0175.Section d4: serial number: (b)(6).Section d4: expiration date: 13 sep, 2023.Section d4: unique device identifier (udi #):(b)(4).Section h4: device manufacture date: 13 sep, 2019.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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18411239
• Report Number: 3012236936-2023-03300
• Device Sequence Number: 20997762
• Product Code: MFK
• UDI-Device Identifier: 05050474579170
• UDI-Public: (01)05050474579170(17)231219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 01/25/2024
• 2 Devices were Involved in the Event: 1 2

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: 09/13/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0240
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2019
• 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: Unknown