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

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown, information was requested but not provided.Section h3-other (81): the device was not returned for evaluation; 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, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's operative eye due to blurred vision.The issue was noted during post-operative examination.The incision was enlarged; however, no vitrectomy or sutures required and no delay in procedure reported.The patient is doing well after the iol exchange and no injury was reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information received from the customer which the following fields were updated accordingly: section b5: additional information received indicated that the affected eye was the right eye.The replacement lens model and diopter used was diu225, 25.5d.No other medical/surgical interventions required.Section a5: ethnicity: non hispanic.Section a5: race: white.Corrected data: upon further review of the event and based on the additional information received which indicated that the replacement lens was of different cylinder with a higher diopter (diu225, 25.5d), this suggests a calculation issue which the patient would have needed a different cylinder and higher diopter to be selected and used for them; therefore, the event no longer meets the criteria for a reportable explant and no further information will be provided under this manufacturer report number 3012236936-2024-00134.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: 18539989
• Report Number: 3012236936-2024-00134
• Device Sequence Number: 17745406
• Product Code: MJP
• UDI-Device Identifier: 05050474747814
• UDI-Public: (01)05050474747814(17)240807
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/21/2024

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: 08/07/2024
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U245
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: White