MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS 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	Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the dfr00v model intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).Pre-operative best corrected visual acuity (bcva) was reported as: on (b)(6) 2023: distance visual acuity (dva): 20-25++ and near visual acuity (nva): 20/130.On (b)(6) 2023: dva 20/40 and nva: 20/30.On (b)(6) 2023: dva: 20/50- and nva 20/20.In a secondary surgical procedure, the iol was explanted and replaced with a dxr00v 20.0 diopter iol.There was no incision enlargement, no vitrectomy, no delay in procedure, no medical attention, and no medication prescribed outside of standard care however unplanned sutures were required.Post-operative bcva was reported as: on (b)(6) 2023: dva: 20/40-2 and nva: 20/50.Patient has fully recovered.No further information is available.
Additional Manufacturer Narrative
Additional information: section b-3: date of event: unknown as information was not provided.The best estimation date is between (b)(6) 2023 and (b)(6) 2023 (iol implant and explant dates).Section h3-81: 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 report will be filed.An attempt was made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: additional information was received confirming the patient was not experiencing unexpected post-op refraction.Patient was dissatisfied with blurry distance vision, floaters, glare, and halos.It was confirmed the unplanned suture(s) were not used as a prophylactic measure.Information regarding date issues were first observed was also provided.No further information is available.The following fields were updated accordingly: section b-3: date of event: 27-nov-2023 section h-6 health effect - clinical code: 1866 - vitreous floaters, 2137 - blurred vision, 2140 - glare, and 2227 - halo.Previous reported code 2138 - unexpected postop refraction is no longer applicable.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 26-jan-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the lens was received in a plastic bag stuck to medical foam.The compliant lens was visually inspected under magnification and was observed to be cut in half and coated in viscoelastic residue.The lens was cleaned and inspected and no issues that could cause or contribute to the complaint issues were observed.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issues could not be confirmed.No product deficiency or product malfunction 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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18437020
• Report Number: 3012236936-2024-00005
• Device Sequence Number: 7024307
• Product Code: MFK
• UDI-Device Identifier: 05050474750678
• UDI-Public: (01)05050474750678(17)240622
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/03/2024

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: 06/22/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU200
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 02/20/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/29/2024; 03/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White