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

Model Number	ZLU225
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Disturbances (2140); Vitreous Loss (2142); Halo (2227)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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 ¿ sutures and vitrectomy.Section h-6 health effect - clinical code: 2140 ¿ glare, photophobia, and visual disturbance.Section h-6 medical device problem code: 3191 ¿ although mechanical failure was reported, it is unknown what the reported issue is for mechanical failure in reference to the intraocular lens (iol).Therefore, device problem code 3191 is being provided for dc-unspecified/other with patient contact.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The zlu225 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Due to complaints of decrease in vision, glare, haloes, light sensitivity, and a visually significant mechanical complication, the patient consented for an operative procedure after a discussion of risks and benefits of the surgery.The iol was explanted in a secondary surgical procedure and replaced with a drt300 15.5 iol.The lids, lashes, and conjunctiva were then meticulously prepared with a 5% betadine solution and the eye was then irrigated with balanced saline solution mixed with dilute betadine.The patient was then draped and a wire lid speculum was placed into the surgical eye.A toric marker was used to mark 8 degrees clockwise of the prior toric marks, at approximately 97 degrees.A 1.0mm side port blade was used to create two paracenteses.Viscoelastic was instilled into the anterior chamber and below the lens and a 2.5 mm single bevel metal keratome blade was used to make the initial incision.The intraocular lens was dissected from the capsular bag using viscoelastic device and dialed into the anterior chamber.The lens was cut in thirds using mst micro-scissors and each piece was removed from the eye.The new drt300 15.5 iol lens was then injected into the eye and rotated into the appropriate axis.Some vitreous was noted at the superotemporal paracentesis, an anterior vitrectomy was performed.Miochol was injected and the pupil was round.Both paracentesis were sutured.Wounds were checked for leakage and confirmed to be secure.Lid speculum was removed and a shield was placed over the eye.Patient was returned to the recovery room in stable condition.Patient prognosis post lens exchange was reported as doing well per doctor post-op note.No further information is available.

• 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: 22638366
• Report Number: 3012236936-2025-000203
• Device Sequence Number: 5267250
• Product Code: MFK
• UDI-Device Identifier: 05050474689862
• UDI-Public: (01)05050474689862(17)250420
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: Health Professional
• Device Expiration Date: 04/20/2025
• Device Model Number: ZLU225
• Device Catalogue Number: ZLU225U155
• Was Device Available for Evaluation?: No
• 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: 07/09/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2020
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White