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

Model Number	DFW300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, patient weight: unknown/no information section b3 date of event: the exact date is unknown.The patient reported approximately one-week post-op.Around (b)(6), 2023.Section d6b, if explanted, give date: not applicable as the iol remains implanted.Section h6- health effect - impact code: 4625, used to capture the secondary surgical intervention for the lens rotation correction surgery.Section h3-other (81): the device has not been 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.Attempts have been made to obtain the missing information; however, that is all the information provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the johnson and johnson (jnj) intraocular lens (iol) was implanted in the patient¿s left eye.Their left eye had a cataract that was beginning to be noticeable and had an uncorrected visual acuity (uva) of 20/500.Their right eye uva is 20/400 but they elected not to treat it.He¿s a long time contact wearer and continues to wear a contact in their right eye.The patient feels his background is applicable to this report and explained that he is familiar with optics as he is a retired computer engineer and manager who is familiar with optics outside the eye.He specifically searched for a surgeon who is experienced with the tecnis synergy toric ii iol.In preparation for the implant in their left eye, the patient previewed several iols, and determined the jnj tecnis synergy toric ii lens is superior because it would give him the ¿widest range of vision free of glasses¿.The patient planned to have intermediate and distance vision as close as possible to 20/20, and if needed wear readers for near vision.Additionally, the patient reviewed the iol specification sheet with a technician but became concerned when the technician said that doctors and technicians usually know better than manufacturers how to use their products.Approximately a week after the iol was implanted in his left eye.Around (b)(6), 2023, the patient experienced blurry vision at an intermediate range.Additionally, several weeks after the surgery his vision had not improved beyond 10/100 and had astigmatism.Patient did not have astigmatism prior to the implant.During a post-op visit, the doctor explained ¿that he had targeted slight myopia for his eye¿.However, the iol rotated 12-17 degrees.The patient said that if the doctor targeted myopia, then that defeats the emmetropia design intended for this lens leading to subpar performance.The patient also said he performed his own calculation using several online calculators.Reportedly, based on the jnj online toric lens calculator his spherical equivalent power (sep) is 11.0 but the surgeon implanted a 12.5.That results in a 1.5 diopter error which he feels is more than a ¿slightly myopic target.¿ based on a visual aid he downloaded from the internet his blurry vision corresponds to an error between 1.75 diopter to 2.0 diopter per the visual aid.The patient sought a second opinion.The second doctor confirmed the iol had rotated and the possible contribution that it could have to astigmatism induced negative acuity effects.This doctor declined the patient¿s request to explant the lens due to his dislike of multifocal lenses in general and had never worked with the synergy lens.Instead, he was advised to go to his first doctor for rotation correction surgery.Three weeks later, the patient had rotation correction surgery with his first doctor.Reportedly, there was no significant improvement in visual acuity 5 weeks after the first surgery and 11 days after the second surgery.The patient sought a third opinion.The third doctor believes that doctor #1 introduced the error to allow the left eye (non-dominant) to be able to see closer-up without glasses while the dominant eye would be targeted for emmetropia.However, the patient said this showed lack of understanding of the synergy¿s optical design.The patient feels this is a problem because he needs to be at 18" or closer for his left eye to focus on 10-point text.Beyond 20", 10-point text becomes too blurry to read comfortably.In contrast, his right eye cannot focus on 10-point text closer than 18" but it¿s still comfortable to read out to about 36".Patient continued to explain that at 10 feet he¿s at 20/100 in his left eye and 20/20 in his right eye.The patient said he now has monocular vision, which he specifically did not want.The patient feels that to achieve balanced vision, he needs additional distance correction in his left eye and close correction in his right eye.The patient clarified that he visited his third doctor and confirmed he has an ora (ocular response analyzer) system.Plus, other sophisticated equipment where almost everything seems automated.The doctor discussed with the patient several options and recommended an explant and replacement.The other option is laser surgery.Doctor provided the patient with a contact lens for his left eye to correct his vision.The contact lens is working, and the patient is satisfied with his vision.The patient declined the explant but is considering laser surgery.No further information was provided.

• 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: 17826075
• Report Number: 3012236936-2023-02438
• Device Sequence Number: 2343229
• Product Code: MFK
• UDI-Device Identifier: 05050474752290
• UDI-Public: (01)05050474752290(17)240307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

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: Lay User/Patient
• Device Expiration Date: 03/07/2024
• Device Model Number: DFW300
• Device Catalogue Number: DFW300U125
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White