MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SYNERGY TORIC II; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Discomfort (2330)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Patient believed she was going to have 20/20 vision after having the surgery and not have to use glasses however, patient cannot see far away.Since the surgery, the patient¿s vision has not getting better.During a post-op appointment, the patient was told by her doctor that since she (the patient) had lasik surgery 6-7 years ago, that the cataract surgery results may not be as good.Patient is not happy she paid a lot to have this model iol implanted & will talk with her doctor about this.Patient has an appointment for a second opinion from a different doctor.The lens is not available for return as it remains implanted.Additional was information was received stating the iol was explanted due to visual complaints of distance and halo/glare.Another johnson & johnson lens was implanted as a replacement (different model iol with a different diopter size, dib00 20.0 diopter).A 2.7mm microkeratome blade was used to make temporal main incision for explant.The original incision was 2.4mm.No sutures were used and no vitrectomy was performed.There was no patient post-explant injury.The lens is not being returned as it was discarded.No other information was provided.
Additional Manufacturer Narrative
Additional information: patient weight and ethnicity: unknown as information was asked but not provided.It was indicated that the iol is not being returned for evaluation as it was discarded therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYNERGY TORIC II
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 13166197
• Report Number: 3012236936-2022-00033
• Device Sequence Number: 14894544
• Product Code: MFK
• UDI-Device Identifier: 05050474751286
• UDI-Public: (01)05050474751286(17)240914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 09/14/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U210
• 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: 12/09/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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 Race: White