MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. 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	Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight and ethnicity: unknown; not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2022.Initial reporter first name: unknown/ not provided.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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient was experiencing severe dysphotopsia and blurry vision in their left eye (os) causing eye strain, resulting in the need to explant the intraocular lens (iol).The patient could not drive and normal activities were significantly affected.The incision was enlarged for the explant, however, no other surgical interventions or delay in procedure reported.A non-johnson and johnson lens of 21.5 diopter was used as the replacement iol.The iol was discarded and will not be returned for investigation.The patient outcome was not provided.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received regarding patient demographics: section a2 age: 61 years.Section a2 date of birth: (b)(6) 1960.Section a3 gender: female.Section a4 weight: 148 pounds.Section a5 ethnicity: not hispanic/latino.Section a5 race: white.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 15299582
• Report Number: 3012236936-2022-02132
• Device Sequence Number: 11364475
• Product Code: MFK
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)241213
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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): 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: 12/13/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU220
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White