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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2020.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, labeling, 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 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 intraocular lens (iol) was explanted from patient's eye and another lens option was replaced.Suspect product was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information: additional information was received on 3/12/2021 confirming the reason for explanting the lens from patient's left eye was due to loss of bcva.Patient had pre-operative bcva 20/30 +2 , ucva 20/200 and post-operative bcva 20/30 -2, however, was experiencing blurry vision.There was no injury and no medical intervention was required.Another lens of same model and diopter (b)(6) was used as the replacement lens and the patient is stable.Patient had a history of myopic lasik and no other prior ocular history.As a result the following fields have been updated: section a2: date of birth: (b)(6) 1962 section a3: gender: female section a5: ethnicity: not hispanic/latino, race : white section e1: email address: (b)(6).Section e1: telephone number: (b)(6).Section h6: health effect - clinical code: 2137 - blurred vision.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
• MDR Report Key: 11398483
• Report Number: 9614546-2021-07079
• Device Sequence Number: 3372855
• Product Code: POE
• UDI-Device Identifier: 05050474605176
• UDI-Public: (01)05050474605176(17)220817
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 08/17/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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: Required Intervention