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

Model Number	DIU150
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Nausea (1970); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported that toric intraocular lens was implanted on (b)(6) 2023 in her right eye and the next day she was unable to see.Patient explained that there is a huge half- moon shadow from the 12 o'clock until the 6:00 o'clock and that she saw five layers stacked.These visual problems had affected her for the last year.Patient is disappointed, upset and reported that she has been terminated from a job as a result of making mistakes due to her visual issues.Few months ago, eye drops were prescribed to shrink eye pupil but his failed and made her unstable, dizzy, nauseous.Glasses were also tried but did not work.She reported that her surgeon insists the lens is properly implanted but that she had gone to four (4) other eye specialists and been told by 3 of them that the lens is out of alignment.The lens was explanted and replaced with a non jnj distance vision only lens in a secondary procedure.
Additional Manufacturer Narrative
H6 - health effect - clinical code 4581 used for device decentered or dislocated or tilted subluxated or wrong position.Product investigation: the product was not returned for evaluation.A record review was performed and no product deficiency identified as all units were released within specification.Based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.Johnson & johnson surgical vision will continue to monitor this type of complaints.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: 18843055
• Report Number: 3012236936-2024-00585
• Device Sequence Number: 7757796
• Product Code: MJP
• UDI-Device Identifier: 05050474746596
• UDI-Public: (01)05050474746596(17)250921
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 03/05/2024

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: 09/21/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U225
• 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: 02/12/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White