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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity and race: unknown as information was not provided.Date of event: unknown as information was not provided.Date explanted: not applicable as the iol remains implanted in the patient's ocular dexter (right eye).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s eye; therefore, a visual 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the an intraocular lens (iol) was implanted in a patient's ocular dexter (right eye).The patient stated that he did not want the iol medi-cal because he would still need reading glasses, so he opted for the top of the line iol.The patient is satisfied with reading, but not with distance.Before the patient had surgery, he had contacts and states he could see better with his contacts.The patient was hoping for 20/20, but his right eye is worse than the left eye.The patient is very unhappy with his right eye and indicated that he is not getting the results he was expecting.He deer hunts often, and now he cannot see good enough out of his right eye to make a good decision.According to the patient, the doctor did a small procedure for astigmatism and he is waiting to see how it goes.No further information is available.Right eye: 20/60.Left eye: 20/20 ¿ 20/25, the patient is satisfied with this eye.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 12919162
• Report Number: 3012236936-2021-00114
• Device Sequence Number: 20231186
• Product Code: HQL
• UDI-Device Identifier: 05050474750593
• UDI-Public: (01)05050474750593(17)240606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 06/06/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2021
• 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: 67 YR
• Patient Sex: Male