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

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon further review, the events of explant and blurry vision were reassessed as not reportable, as there is no allegation or deficiency reported against the lens.It is indicated that the either human error in quality of measurement or ocular surface variability.Hence, the information from the initial mdr pertaining to the earlier mentioned codes 4629 - device revision or replacement 2137 - blurred vision and reportability (section b1 and b2) are no longer applicable and case is considered as not reportable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional narratives/data: device evaluation: the product testing could not be performed as the product was discarded by the account and not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the monofocal toric intraocular lens was exchanged on (b)(6) 2024 due to an underpowered toric.The lens has been disposed of, so we will not be able to send it back.Additional information revealed it happen due to either human error in the quality of measurement or ocular surface variability, with no issues post-op.The patient was seen pow 1 s/p toric iol exchange and is pleased with her vision and notes improvement.Further additional information suggests the patient had blurred vision and optical distortion secondary to residual uncorrected astigmatism.No further information is available.

• 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: 19261861
• Report Number: 3012236936-2024-01227
• Device Sequence Number: 15082997
• Product Code: MJP
• UDI-Device Identifier: 05050474746640
• UDI-Public: (01)05050474746640(17)241214
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U250
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White