MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deposits (1809); Dry Eye(s) (1814); Blurred Vision (2137); Unspecified Eye / Vision Problem (4471); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown; not provided.The best estimate date is between nov 3, 2015 and dec 8, 2025.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3: the device was not returned for evaluation as it remains implanted; 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 will be filed.Section h6: health effect - impact code 4625 (additional surgery) is to capture the laser treatment.Section h6: health effect - impact code 4613 (minor injury/illness/impairment) and health effect - clinical code 4471 (unspecified eye/vision problems) is to capture the 'bubble' in the eye.An attempt was made to obtain the missing information; however, no additional information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the patient that after the non-preloaded multifocal intraocular lens (iol) was implanted in the left eye, the patient experienced difficulty with both distance and near vision, stating that the lens had not performed well.In 2017, the patient developed a 'film' in the left eye, which was treated with laser, resulting in improved vision.Later, the patient experienced a 'bubble' in the left eye that resolved on its own.Recently, the patient's vision worsened significantly, and during a vision test, was unable to see the top line of the chart.The patient was diagnosed with dry eye and was recommended glasses; however, the patient was concerned that the iol might be faulty, as the patient was informed that there were no other issues with the eye despite the worsening vision.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that section h6 health effect - clinical code 1809 (deposits) was included on the initial mdr but should be changed to health effect - clinical code 4807 to better capture the event of ¿the patient developed a 'film' in the left eye, which was treated with laser, resulting in improved vision¿.Therefore, it is captured in this supplemental report.The following field has been updated accordingly: section h6 health effect - clinical code 4807 (posterior capsule opacification).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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 23944226
• Report Number: 3012236936-2026-000003
• Device Sequence Number: 20794825
• Product Code: MFK
• UDI-Device Identifier: 05050474535701
• UDI-Public: (01)05050474535701(17)171204
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 12/04/2017
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0240
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2013
• 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: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White