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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, remains implanted in the eye.Explant was planned, however, no information was received that it was performed.The device was not returned for evaluation as the lens remains implanted in the eye.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.Health effect - impact code: 4644 - medication required- used to indicate the medical intervention and topical steroids.Health effect - clinical code: 4581- eye anatomy issue.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that intraocular lens (iol) was explanted from patient's operative eye due to extreme dysphotopsia, however, additional information received revealed that the explant was planned but no information was received confirming that it was performed.Additional information received revealed that it was a dfr00v intraocular lens that was implanted in the patients left eye.During the one week post operative examination on (b)(6) 2023, intraocular pressure was elevated to 23 and patient had a paracentesis done.The vision was ok but still blurry at near and distance and the vision was worse in more lighting.Patient had foreign body sensation (fbs) since the morning of the one-week examination date.Patient was using simbrinza, prednisolone/moxifloxacin one drop four times a day and was asked to continue using prednisolone and alphagan twice a day in os (ocular sinister).During post operative examination on (b)(6) 2023, it was noted that the patient had worn contact lens for 1.5 hours after last appointment, but eye was teary and scratchy so took out and hasn't worn.The intraocular pressure was improved to16 and cornea was clear.The patient was asked to continue the same medication and was instructed to taper lumigan to qhs ou (oculus uterque).Patient was asked to take diamox twice a day of explant and patient was scheduled for iol insertion os to get implant in, however, no information was provided that it was performed.Patient had an history of retinal tear and retinal surgery and vitrectomy were performed prior to the implantation of the original lens.
Additional Manufacturer Narrative
Additional information was received from the facility and following fields are being updated accordingly: section b5: additional information received from the facility revealed that the original lens was explanted and a different model lens (dib00) was used as the replacement.The patient was asked to discontinue lumigan and simbrinza and was advised to continue taking already prescribed prednisolone/moxifloxacin two time a day in left eye.The original lens was discarded.No other information was provided.Section d6b: if explanted, give date: on (b)(6) 2023.Section h6: health effect - impact code: 4629 - device revision or replacement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 16514358
• Report Number: 3012236936-2023-00522
• Device Sequence Number: 6611166
• Product Code: MFK
• UDI-Device Identifier: 05050474750593
• UDI-Public: (01)05050474750593(17)240331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU160
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Race: White