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 Code	Blurred Vision (2137)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a, patient information: a2, a4, a5: information unknown/asku.Section b3 date of event: the exact date is unknown.The best estimate is between the implant and explant dates.(b)(6) 2017 - (b)(6) 2023, respectively.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.Attempts have been made to obtain the 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 johnson and johnson(jnj) intraocular lens (iol) was explanted.The patient has not been happy with the side effects for years but waited until now because they were fearful of the exchange.The patient was experiencing blurry vision.The replacement lens is a non jnj iol.The customer did not save the suspect product consequently it will not be returned to jnj.No further information was provided.
Additional Manufacturer Narrative
Additional information was received from the customer.This supplemental report is to correct the initial submission based on the additional information received.The patient¿s vision was hazy at all ranges.The first awareness date of the symptom is (b)(6) 2021.The patient¿s date of birth is (b)(6) 1950.Affected eye is the left eye.Patient¿s race is african american, and ethnicity is not hispanic or latino.There was no patient injury.No vitrectomy and no incision enlargement.The diopter for the replacement lens is 16.5 (non jnj lens).Vision was hazy at all ranges.The patient outcome is ¿good¿.The following fields were updated accordingly: section a2, age or date of birth: (b)(6) 1950.Section a5, ethnicity: not hispanic/latino.Section a5, race: black or african american.Section b3, date of event: december 22, 2021.Section b5, describe event or problem: the patient¿s vision was hazy at all ranges.Affected eye is the left eye.There was no patient injury.No vitrectomy and no incision enlargement.The diopter for the replacement lens is 16.5 (non jnj lens).The patient outcome is ¿good¿.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient¿s vision was hazy at all ranges.Affected eye is the left eye.There was no patient injury.No vitrectomy and no incision enlargement.The diopter for the replacement lens is 16.5 (non jnj lens).The patient outcome is ¿good¿.

• 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: 16823122
• Report Number: 3012236936-2023-00965
• Device Sequence Number: 6820306
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)220518
• 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 Implanted Year: 2017
• Device Explanted Year: 2023
• 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): 11/14/2023

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: 05/18/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: Black Or African American