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

Model Number	DIU375
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Flashers (1864); Vitreous Floaters (1866); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient reported that he was implanted with a lower end intraocular lens (iol) instead of getting a better iol.That the physician told him, he would not wear glasses anymore, but the patient is still wearing glasses and is not satisfied with his vision.The patient saw his doctor recently and was informed that the lens in the right eye has rotated 11 degrees and the lens in the left eye has rotated 6 degrees.The patient stated that he is experiencing blurry vision, floaters and starburst in both eyes.The patient has difficulties with driving, reading and seeing things; however, he accepts that he is still able to do his daily tasks although sometimes with difficulty.The patient was seen by his doctor on (b)(6) 2022 which re-rotation and flattening of the right eye lens was performed during that visit.No action was taken with the left eye.The patient indicated that the re-rotation has not made much difference.The patient is scheduled to see his doctor again on (b)(6) 2022.No further information was provided.
Additional Manufacturer Narrative
Ethnicity/race: the exact ethnicity and race are unknown/ information asked but indicated to be "mixed".Date of event: unknown, not provided, but the best estimate date is after (b)(6) 2021.Implant date: if explanted, give date: not applicable, as the lens remains implanted.Device evaluated by mfr: the device is not returning for evaluation as the lens remains implanted; 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 & johnson surgical vision, inc.Has been submitted.

• 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: 15153831
• Report Number: 3012236936-2022-02072
• Device Sequence Number: 17491544
• Product Code: MJP
• UDI-Device Identifier: 05050474748347
• UDI-Public: (01)05050474748347(17)240304
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: DIU375
• Device Catalogue Number: DIU375U215
• 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: 07/07/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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: Male
• Patient Weight: 105 KG