MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	DFR00V
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a dfr00v model intraocular lens(iol) was explanted from patient's left eye due to mechanical failure.There was no patient injury.No medical or surgical intervention was required.No further information available.
Additional Manufacturer Narrative
Additional information received revealed that the mechanical failure initially reported was that the patient stated she was unable to adapt to the lens and unhappy with glare.There was also no issue with the lens.No additional surgical/ medical interventions were done.The lens was exchanged to monofocal lens due to patient unable to adapt to vision with a multifocal lens ie, glare.The patient was doing stable at the time of discharge.The replacement lens used is a different model same diopter lens.Patient did not experience loss of 2 or more lines bscva.Visual acuity pre-op (pre-initial implant): corrected vision os 20/20-2.Visual acuity post-op (post-initial implant): corrected vision os 20/25-2.Visual acuity post-op (post-replacement): corrected vision os 20/25.As a result the following fields have been updated: section a5: race: not hispanic or latino.Section b3: date of event: (b)(6) 2021.Section h6: corrected data: health effect- clinical code: 2140- glare.Section h6: corrected data :medical device problem code : 2993 ¿ no reported issue lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes, returned to manufacturer on 12/9/2021.Section h3: device returned to manufacturer: yes.Device evaluation: visual inspection of the return sample shows the product is cut in half, most probably to make explant possible.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed that no similar complaints were received for this production order number.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: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12538249
• Report Number: 2020664-2021-07551
• Device Sequence Number: 4102330
• Product Code: HQL
• UDI-Device Identifier: 05050474750746
• UDI-Public: (01)05050474750746(17)240318
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 02/16/2022

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: 03/18/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 02/10/2022
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/26/2021; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic