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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a5 (ethnicity): unknown/ not provided.Asku.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section h3-other (81): the device was not returned 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.Attempts have been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient cannot read anything with her operated eye (left eye) for > 1 month now after being implanted the intraocular lens (iol).It was learned that the patient considers the visual problem debilitating precisely because she is unable to perform her regular activities, which she could still do before cataract surgery and lens implantation.She is unable to see small details in figures and names, both up close and from a distance, and at night, car headlights and lamps bother her a lot because she sees everything blurry and overly bright.It was noted that the visual issues immediately occurred after removing the bandage.Computerized corneal topography (topography) of the left eye and optical coherence tomography (oct) macular of the left eye were to be performed in the coming week.No other information was provided.

• 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: 17088315
• Report Number: 3012236936-2023-01330
• Device Sequence Number: 6088640
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)240807
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: 08/07/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• 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: 05/20/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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: Other
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White