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

Model Number	DIU300
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a doctor had to exchange a monofocal toric intraocular lens (iol) for a different power due to a refractive surprise.The replacement lens was replaced was of the same model and cylinder but of a higher diopter (19.5d).There were no surgical complications and original lens was discarded.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not available.Section b3: date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2024 and (b)(6) 2024.Section h3(no): the device was not returned for evaluation as it was discarded; 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 additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the surgeon calculated the incorrect power of the toric lens ( toricity).It is believed that the patient is doing fine.That it was not a lens issue, it was a mistake by the account to calculate it correctly.The following field was updated according the new information received: section h6: device code(s): 1189 - application program problem: dose calculation error corrected data: upon further review of the event and based on the additional information provided, since the explant was due to calculation error which an incorrect lens power (diu300, 17.0 diopter) was initially calculated and implanted by the account instead of a lens (diu300, 19.5d); therefore, the event no longer meets a reportable explant criteria and no further report will be submitted under this manufacturer report number 3012236936-2024-0003169.The following device code is no longer applicable: section h6: device code(s): 2993 - adverse event without identified device or use problem 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: 20800359
• Report Number: 3012236936-2024-000316
• Device Sequence Number: 15161731
• Product Code: MJP
• UDI-Device Identifier: 05050474747661
• UDI-Public: (01)05050474747661(17)260821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 08/21/2026
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U170
• 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: 11/03/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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: 68 YR
• Patient Sex: Female