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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Posterior Capsule Opacification (4807)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: exact date is unknown/not provided.It was stated that the symptoms started right after the lens was implanted on (b)(6) 2022).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.Section h6: health effect - impact code: 4625 yag (yttrium aluminum garnet).An attempt has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was explanted from the patient¿s operative eye due to mechanical complications of iol which the patient¿s vision was blurry and the patient was unable to tolerate the lens.Patient¿s daily activities were significantly affected.The patient is status post (s/p) yttrium-aluminum-garnet (yag) so a planned vitrectomy was required.It was indicated that the yag was done due to posterior capsule opacification (pco) that had a significant impact on the patient¿s vison at 5 week post-op appointment.After the lens explanted, a non-johnson and johnson lens of 23.0 diopter was used as a replacement lens.No incision enlargement or sutures required and no delay in procedure reported.Medications (prednisolone 1% -moxifloxacin 0.5% - bromfenac 0.075% 1 drop 4 times a day /1 gtt qid in the right eye) prescribed were standard or care drops which are given to patients before and after any lens procedure.The patient is temporarily impaired.Vision pre-operative with correction 20/15-1 and vision post-operative without correction 20/40.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: apr 25, 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint lens reveal that it was cut in half with a haptic cut/detached and missing.The lens was cleaned, presenting with no issues that would have caused or contributed to the complaint event.The complaint issue "explant, blurry vision, yag, and pco : posterior capsule opacification" 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.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 19141264
• Report Number: 3012236936-2024-01162
• Device Sequence Number: 7833499
• Product Code: MFK
• UDI-Device Identifier: 05050474750739
• UDI-Public: (01)05050474750739(17)241120
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: 11/20/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU230
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• 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: 53 YR
• Patient Sex: Male