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

Model Number	DFW300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Received report indicating the iol was explanted from the patient¿s right eye due to 2/2 cloud over vision, dull colors, difficulty with near and intermediate vision.The customer reported the patient¿s vision as post-operation (po) m.R: +.75-.75 x 178 se:+.37.Their uncorrected distance visual acuity (ucdva) at one month po 20/30+, uncorrected near visual acuity (ucnva) j2.There was no vitrectomy required and the incision was not enlarged.The replacement lens is model zcu300 diopter 18.0.Reportedly, the patient is doing fine.No further information was provided.
Additional Manufacturer Narrative
Additional information: upon further review of the file it was noted that a follow-up report is required.Therefore, this supplemental filing is to update the following fields: section a2 - date of birth: (b)(6) 1947.Section a4 - patient weight: 166 pounds.Section a5 - ethnicity and race: non-hispanic, white.Section b5 - describe event or problem: account provided patient was dissatisfied.They experienced dark, grayed-out cloud over vision and could not watch television or read.The affected eye is the right eye.Event had no medical or surgical intervention required.Corrected data section b3 - date of event: (b)(6) 2021.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Additional information: device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jul 22, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of the replacement lenses lens case (sn:80871936) per the initial report.Additional documentation was received as well.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could contribute to blurry vision or visual disturbances could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issues "hm-blurry vision", "hm-visual disturbance- dysphotopsia", and "hm-sub-optimal results" were not confirmed.No additional issues could be observed during product evaluation.Conclusion: based on the investigation there is no indication of a product deficiency or product malfunction.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 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: 12564983
• Report Number: 2020664-2021-07420
• Device Sequence Number: 20273660
• Product Code: MFK
• UDI-Device Identifier: 05050474752399
• UDI-Public: (01)05050474752399(17)240331
• 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): 09/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: DFW300
• Device Catalogue Number: DFW300U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 10/24/2021; 09/29/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/15/2021; 11/02/2021; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White