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

Model Number	DIU225
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date: not applicable, as lens was removed/replaced during the same procedure.Explant date: not applicable, as lens was removed/replaced during the same procedure.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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was fully implanted and removed from the right eye because a vitrectomy was needed.Per the doctor, there was a posterior defect noted in the capsular bag and due to instability of the lens, the decision was made to explant.The instability of the lens was due to a capsular defect.There was no product issue.The issue was first observed after the lens was fully implanted and then it was cut out and replaced within the same procedure.The incision was enlarged and one suture and a vitrectomy were required.A non-johnson and johnson three-piece iol was implanted as replacement.The replacement lens was "dialed in" without issue.The doctor does not know if the "defect" was a result of the attempt to implant the iol or if it was a patient biological issue.The patient was doing well at the post-op visit.No further information is available was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 13, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no further issues could be observed that could cause or contribute the complaint issues.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue "positioning issue" was not identified during product evaluation.Therefore, there is no indication of a product deficiency or product malfunction.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.

• 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: 15943491
• Report Number: 3012236936-2022-03019
• Device Sequence Number: 15053865
• Product Code: MJP
• UDI-Device Identifier: 05050474747159
• UDI-Public: (01)05050474747159(17)251018
• 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
• 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): 01/27/2023

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: DIU225
• Device Catalogue Number: DIU225U210
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/27/2023
• 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 Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White