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 Codes	Vitreous Loss (2142); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the diu300 model intraocular lens (iol) was fully implanted and removed during the same procedure due to vitreous in the anterior chamber.The incision was enlarged, suture(s) and vitrectomy were required.The procedure was completed using a non-johnson & johnson surgical vision sulcus lens that was implanted in the patient¿s ocular sinister (left eye).A patient anatomy issue was attributed to the reported event and not a product quality issue.Patient outcome post-procedure was reported as customer unaware of any issues.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure, therefore not explanted.Section h3-81: 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 report will be filed.Section h-6 health effect - impact code: 4625 incision enlargement, sutures, and vitrectomy.Section h-6 health effect - impact code: 4631 iol removal and replacement.Section h-6 health effect - clinical code: 4581 incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 20-mar-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint simplicity was received inside the original folding carton and a loose lens was also received.The simplicity was visually inspected under magnification and no damage or issues were observed with the cartridge, lens module, plunger, or handpiece assembly.The lens was visually inspected revealing that the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected, and no issues that could cause or contribute to the complaint issues were observed.Complaint issue "removal and replacement", "vitreous in the anterior chamber", "unplanned vitrectomy", "sutures", and "incision enlarged" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issues could not be confirmed.No product deficiency or product malfunction was identified.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: 18913794
• Report Number: 3012236936-2024-00714
• Device Sequence Number: 6760346
• Product Code: MJP
• UDI-Device Identifier: 05050474747722
• UDI-Public: (01)05050474747722(17)251018
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/25/2024

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: 10/18/2025
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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 Age: 75 YR
• Patient Sex: Female