MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	08/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the left eye due to severe halos, glare, and lack of near vision.A non-johnson & johnson 3-piece iol was implanted as replacement.It is unknown if there was any patient injury or if medical or surgical intervention was required.The patient is stable post-operatively with the new lens, with a 3+ posterior capsule opacification (pco).The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Date of event: unknown; requested but not provided.The best estimate date is between aug 2019 and aug 29, 2022.If implanted, give date: unknown, information was requested but not provided.The best estimate date is aug 2019.The device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Multiple attempts have been made to obtain additional information regarding the event; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up, it was learned that the patient's original date of implant was (b)(6) 2019 and the symptoms were first noted on (b)(6) 2019.The patient's pre-operative corrected near vision visual acuity (va) was j1+, pre-operative uncorrected va was j3.The patient's post-operative corrected near vision visual acuity (va) was not checked, post-operative uncorrected va was j6.Th patient was last seen on (b)(6) 2020 and at the time the patient's spectacle corrected distance visual acuity (scdva) was 20/30 and the mrx showed -0.50+0.50x120 and va was 20/20.The spherical equivalent of the mrx would be -0.25sph and the surgeon aims for -0.15 to -0.25.No further information was provided.The following sections have been updated accordingly: section a5: ethnicity: not hispanic/latino section b3: date of event: (b)(6) 2019.Section d6a: if implanted, give date: (b)(6) 2019.Section d4: model number: zxr00.Section d4: serial number: (b)(6).Section d4: catalog number: zxr00u0205.Section d4: expiration date: aug 2, 2023 section d4: unique identifier (udi) number: (b)(4).Section h4: device manufacture date: aug 2, 2018.Section h3-other (81): the device was not returned 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 15494616
• Report Number: 3012236936-2022-02444
• Device Sequence Number: 6090817
• Product Code: POE
• UDI-Device Identifier: 05050474579101
• UDI-Public: (01)05050474579101(17)230802
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 10/13/2022

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: 08/02/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0205
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White