MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Eye Pain (4467)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens the lens remains implanted.(b)(4).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 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted in the right eye that patient experienced defined halos and glare.Distance images are clear with right eye (shape of leaves, road signs, etc).The patient can drive however, the patient avoids night driving.Through follow-up with the patient, it was learned that the patient currently still experiences halos and glare around house lights and oncoming vehicle traffic with the right eye.The patient has experienced more dry eye symptoms and uses over-the-counter lubricating drops (systane).The patient reported that the visual issues in the right eye are not affecting daily activities.The visual issues started the day after surgery and clarity improved over two to three months.The patient had more dry eyes until two to three months post-surgery.Glare persists however, the patient can drive during the night cautiously (with increased getting used to the lens).After completion of the one-month use of typical post-surgery eye drops, the patient still experienced some pain, dryness, discomfort, and the patient¿s vision was blurry.The doctor instructed the patient to continue use of an additional one month of steroid eye drops, three times per week, then two drops the third week, and one drop the fourth week.It took about three to four months to have clearer vision.There are no planned interventions for the right eye.Prescription for right eye: -5.25 sph; -0.75 cyl; 060 axis; reading addition: +2.50; the patient wears acuvue 1day moist multifocal contact -5.00/m.The patient reported visual acuity in the right eye is 20/25 and noted that near vision is better with the lens in the left eye.The iol remains implanted.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 15097453
• Report Number: 3012236936-2022-01983
• Device Sequence Number: 12070735
• Product Code: POE
• UDI-Device Identifier: 05050474591714
• UDI-Public: (01)05050474591714(17)240130
• 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: 2020
• 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): 07/25/2022

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: 01/30/2024
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0135
• 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: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• 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; Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian