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	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter phone number: (b)(4).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's left eye due as the patient refracted a bit myopic, could not read well and the distance was blurred.When the doctor corrected that the patient reported that her near was even worse and the patient had early posterior capsule opacification (pco).The patient was not unhappy with the symphony toric lens.The original lens implanted was selected using iol master 700, alcon ora guidance and flac.For the explant procedure, the same incisions accessed and no vitrectomy, no sutures and no complications were reported.A replacement lens of different model and diopter (20.5d) was used.It was indicated that there was no yttrium-aluminum garnet (yag) capsulotomy performed, but it will be required to achieve best vision later.Reportedly, the patient's other eye is emmetropic with an immature cataract and dry eye which is not ready for surgery.Patient's symptoms on the left eye: on (b)(6) 2021, poor near vision.On (b)(6) 2021, poor far sc 20/40, near j7.On (b)(6) 2021, worse far sc 20/60, refraction myopic -1.00+0.75@95 but cc near poor, far not subjectively acceptable with refraction, early pco2+.Oct nl macula.But ocular surface disease/ dry eye present.Post-op day-1 after the lens was explanted: comfortable, mild corneal edema, normal pressure.Next appointment for vision and refraction was reported to be in 4 days.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 11987459
• Report Number: 9614546-2021-07217
• Device Sequence Number: 4380908
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)240304
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/25/2021

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: 03/04/2024
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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
• Patient Weight: 47