MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).Attempts have been made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient has a ¿smudge¿ in the central vision with the intraocular lens (iol).The surgeon is planning to explant the iol on (b)(6) 2022 and implant another johnson & johnson iol (different model, zcu).Through follow-up, it was learned that the iol was implanted in the right eye and the "smudge" is a visual disturbance the patient is experiencing, like a blob of grease.The lens looks clear.There is minimal capsular opacity.Optical coherence tomography (oct) of macula is normal.Bcca: -0.25 +0.75 x 95 20/25.The patient is unable to see the tv or computer and is having difficulty at work.An explant is planned for aug 22, 2022.Through additional follow-up, it was learned on aug 25, 2022 that the iol was explanted on aug 22, 2022.The surgeon used a 2.75 mm keratome for the explant surgery and used a 2.4 mm keratome for the first surgery.Another johnson & johnson iol was implanted as replacement (different model, zcu150, different diopter of +20.5).The second surgery did have a slightly larger incision.No other interventions were required.There were no complications or injury to the patient.The patient is doing well.The patient's uncorrected vision is 20/40 post operatively day two.The patient no longer sees the central smear.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15423125
• Report Number: 3012236936-2022-02370
• Device Sequence Number: 7709282
• Product Code: MJP
• UDI-Device Identifier: 05050474746541
• UDI-Public: (01)05050474746541(17)250327
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: 03/27/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U200
• 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: 08/25/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2022
• 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