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

Model Number	DFR00V
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Halo (2227); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown; 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.Section h6: health effect - clinical code: code 4581 is to capture device decentered or dislocated or tilted subluxated or wrong position, and code 4580 is to capture "balance issues".Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the left eye due to dislocation, halos, and balance issues.The patient did not have a debilitating condition due to these issues.The patient does not have any pre-existing medical history issues.A non-johnson and johnson light adjustable lens (lal) was implanted.No additional surgical interventions were required.There was no patient injury.The patient is ¿ok¿ post-operatively.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jul 26, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: two lenses were received for evaluation with no identifying information; therefore, both lenses were evaluated and the results are provided in this report.Sample 1: visual inspection under magnification revealed that the complaint lens was received cut in half (one half missing).The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue of ¿instability of device after implantation¿ was not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Sample 2: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.Based on the return.The complaint issue of ¿instability of device after implantation¿ was not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be 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: 17135960
• Report Number: 3012236936-2023-01497
• Device Sequence Number: 20338760
• Product Code: MFK
• UDI-Device Identifier: 05050474750548
• UDI-Public: (01)05050474750548(17)240403
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2023
• 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): 09/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU135
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2021
• 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 Sex: Male
• Patient Race: White