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

Model Number	DXR00V
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
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
Section a3b, gender: "male".Section b3, date of event: the exact date is unknown.The best estimate is during a post-operative visit approximately one week after the implant.Section d6a, if implanted, give date: the best estimate is around (b)(6) 2024.Section d6b, if explanted, give date: not applicable as it remains implanted.Section h3, device evaluated by manufacturer: 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 and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain the missing information.However, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s right eye around (b)(6) 2024.The patient said his whole goal was to be able to read without glasses.Instead, he still has many glasses that he uses to read.The patient said that he may not have told his doctor that his goal was to be able to read without glasses.The patient experienced blurred vision in his right eye which his doctor attributes to his macular degeneration.The doctor explained to the patient that his macular degeneration is not due to the iol.The issue was first noticed during a post-operative visit approximately one week after the implant.Initially, the doctor had scheduled an explant but was subsequently cancelled.His doctor said the iol moved and in (b)(6) 2024 the lens was repositioned.The patient said he will seek a second opinion.No further information was provided.
Additional Manufacturer Narrative
The initial report 3012236936-2025-0001519 should have included the following information.This current report provides the correction below.Section h6, health effect - impact code: 4625 - additional surgery, is being used to capture the secondary surgical intervention to reposition the iol inside the patient's eye.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 22102352
• Report Number: 3012236936-2025-000151
• Device Sequence Number: 7060584
• Product Code: POE
• UDI-Device Identifier: 05050474761803
• UDI-Public: (01)05050474761803(17)250408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU205
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• 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: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White