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

Model Number	ZXR00
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The best estimate is a few weeks after dec 13, 2021.The device has not returned for evaluation.Therefore, a visual 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
Received report from a patient indicating her left eye is for close-up reading.The patient explained that when she reads the vision in her left eye is a little blurry.She is very disappointed with that outcome.The patient provided that when she first walked out of the office after her implant she looked around and her vision was clear.She was happy.However, she was not trying to read anything up close.She did not try to read until a couple of weeks later.That is when she noticed her reading vision was blurry.The blurriness is within arms-length.The doctor told her that the iol seemed a little hazy and performed yttrium aluminum garnet (yag) lasik surgery on (b)(6) 2021.The patient said it did not help.Patient stated she¿s healthy, does not have high blood pressure and is not on any prescription medication.She only takes vitamins.Reportedly, the doctor explained to her that she needed time to allow for neuroadaptation.First the doctor said to give it a couple of weeks but then he extended it to a couple of months.He then prescribed glasses.She got glasses on (b)(6) 2021.The glasses were not working for her either.The doctor modified her prescription slightly on (b)(6) 2022.She is waiting for her new glasses and hopes those will work better.No further information was provided.
Additional Manufacturer Narrative
Upon further review of this event it was determined that code 4581 is a better fit for the reported event.Therefore, the following correction is being made to the initial filing under report number 3012236936-2022-00698.Correcting section h6, medical device problem code 1170 - material discolored.Removing this code and replacing it with section h6, health effect - clinical code 4581 - no code available (posterior capsule opacification) all pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• 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: 14018215
• Report Number: 3012236936-2022-00698
• Device Sequence Number: 12337335
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)240129
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 01/29/2024
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White