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

Model Number ZLB00

Device Problem Break (1069)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.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 complaint awareness dates).Section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section h3-81: the device was not returned for evaluation as it remains implanted in the patient¿s ocular dexter (right eye).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.Section h-6 health effect - impact code: 4625 yag attempts were 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.

Event Description

It was reported the zlb00 model intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).Patient reports complaints of not much improvement and vision may be worse than what he came in with.There is not the clarity as there is in the ocular sinister (left eye) and he equates it to looking through a filtered lens.He also reports there is a section that is blurry or out of focus that seems to be the bottom half of my sight when trying to read something; like just opening your eyes in the morning except it's 24/7.A yttrium aluminum garnet (yag) procedure was performed.According to a retina specialist, there is nothing about the patient's eye's "health" that would contribute to the patient visual issues.However, a small crease was noted but the retina specialist did not think it contributed to the reported complaints.The retina specialist referred the patient back to the cataract surgeon.Patient stated if both eyes were like this at night he would not be able to drive.Patient is annoyed to have filtered blurry vision from one eye and be told his eye is healthy.Sales rep reported complaints cloudy vision, blurry vision, like something is in front of it at distance and near.Patient had a yag laser but it did not help.Patient was also seen by retina and got a clear report with no issues.Vision: 20/30 and ph: 20/25.The suspect iol is not available for return as it remains implanted.There are no issues with the iol that was implanted into the patient's ocular sinister (left eye).Patient stated os iol has been a wonderful addition to my eyesight, more clarity and better vision for reading.No further information is available.

Manufacturer Narrative

Additional information: through follow-up, additional information was received stating yag was performed (b)(6)2023.Patient also sated his surgeon has not follow-up with retinal specialist's small crease diagnosis.Patient demographic information was also provided.No further information is available.The following fields were updated accordingly: section a-2 patient date of birth: (b)(6) 1961.Section a-4 patient weight: 200 lbs.Section a-5 patient ethnicity: not hispanic.Section a-5 patient race: white.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: 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: 18548472
• MDR Text Key: 333315286
• Report Number: 3012236936-2024-00143
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474560666
• UDI-Public: (01)05050474560666(17)270728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White