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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Headache (1880); Red Eye(s) (2038); Blurred Vision (2137); Visual Impairment (2138); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.Date of event: unknown, not provided.Best estimate (b)(6) 2021.Manufacturer telephone number: (b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted due to the patient could not pinhole to better than 20/40.There was no incision enlargement and no vitrectomy required.The patient is doing fine post-explant.Ab 20/40, ph 20/40 corrected distance, 20/30 intermediate, j3 refraction 20/30 -.25-.50, mac/oct (macular/optical coherence tomography) had normal pre and post -operative (op) scan.The explanted lens was replaced with aab00 iol, but the serial number is unknown.No other information was provided.
Additional Manufacturer Narrative
Additional information: upon further review a duplicate file was received with new information of additional reason for explant blurred vision, foreign body sensation, irritation, headaches.Therefore, the following sections have been updated.Section h6: health effect: clinical code: 2137: blurred vision section h6: health effect: clinical code: 1869: foreign body sensation section h6: health effect: clinical code: 2038: red eyes section h6: health effect: clinical code: 1880: headache all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: 9/27/2021.Section h3.Device evaluated manufacturer? yes.Device evaluation: the product was received in the lens case of the replacement iol.Product was inspected.On the posterior side of the lens a concentric ¿deformation¿ is observed between the first and second diffractive rings counted from the optical center.The lens was additionally inspected by norm committee member.The following observations were made: the observed ¿deformation¿ was confirmed to be part of the lens design and does not reflect a lens defect.The returned lens was measured for mtf (measure true focus) value.The product meets mtf specifications per pzfr00v and rp6319r, refer to attachment 02.Based on the reported event, the following potential contributing factors were considered: miq (measuring image quality) data base has been reviewed and the results of the reported serial number is within specification.The complaint cannot be confirmed.The previously investigated complaint list amo-04-d014 was reviewed.There are no previously investigated complaint (pic) associated with these codes.The product investigation matrix amo-04-d024 rev07 was reviewed.Per complaint investigation procedure amo-04-s006 this complaint will be investigated as high risk, level 3 investigation.The complete complaint information is documented and the complaint coding is accurate.No escalations are required.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.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.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that code assigned in the 1st supplemental report submitted in section h6: health effect clinical code: red eyes 2038 is incorrect.Correct code should be hm-eye irritation: 4803.This report is submitted to correct this.Field below updated.Section h6: health effect clinical code:4803 (to capture eye irritation).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 ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 12243032
• Report Number: 9614546-2021-07305
• Device Sequence Number: 19749918
• Product Code: HQL
• UDI-Device Identifier: 05050474750722
• UDI-Public: (01)05050474750722(17)240320
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2023

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: 03/20/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU225
• 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: 07/01/2021
• Supplement Date Received by Manufacturer: 10/24/2021; 04/12/2022; 12/02/2023
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/17/2021; 04/18/2022; 12/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2021
• 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 Sex: Female