MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number DFW150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

Section a4 (patient weight) and a5 (ethnicity): information requested but was not provided.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section e1.Telephone number: (b)(6).Section h3-other (81): the intraocular lens (iol) was not returned for evaluation; 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.Section h6: health effect - clinical code - 4581 sub-optimal result.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported a patient with distance vision issues after intraocular lenses was implanted in (b)(6) 2022.Customer anticipated a residual prescription of +0.26 sphere -0.21 cylinder in the right eye.However, the patient progressed with a prescription of -0.50 -0.75 in the right eye.Patient recently underwent laser refractive surgery, photorefractive keratectomy (prk) to correct the residual prescription.Uncorrected visual acuity binocular 20/30 partial for far/ near jaeger j1.Monocular 20/40 for far.Prescription -0.50 -0.75 140 (20/20) no further information was provided.This is report 1 of 2 and it pertains to patient's right eye (od).

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• 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: 17654769
• MDR Text Key: 322330145
• Report Number: 3012236936-2023-02226
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474711129
• UDI-Public: (01)05050474711129(17)240723
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

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
• Device Operator: Health Professional
• Device Model Number: DFW150
• Device Catalogue Number: DFW150I235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White