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

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the lens (iol) was explanted from the patient's left eye.The implanting doctor reported the patient was not completely happy with her vision after surgery over a four month period.There were no surgical complications.The clinic was trying to address the patient¿s pre-existing severe dry eye and corneal issues.The patient had a prior lasik surgery and has had episodes of dry eye over the years.The patient sought a second opinion from several local surgeons.A local surgeon explanted the jnj iol due to the patient experiencing blurry vision and halos.Reportedly, the symptoms were experienced soon after the implant.There were no complications such as capsule tear, vitrectomy or sutures.The patient is doing well.The explanted iol will not be returned to jnj as it was discarded by the doctor's office.No further information was provided.
Additional Manufacturer Narrative
Section a, patient information: a4, a5: information unknown/asku.Section b3 date of event: the exact date is unknown.It was reported soon after the implant.Section h6- health effect - clinical code: 4581, this code was used for the reported a pre-existing eye issue.Section h3-other (81): the device was not returned for evaluation as it was discarded.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.Attempts have been made to obtain the missing information, however, it is not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: this is to correct the initial submission section h6, health effect - clinical code: should have included the code 2227 for halos.Field below is updated: h6, health effect - clinical code: 2227 - halos.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: 16820709
• Report Number: 3012236936-2023-00838
• Device Sequence Number: 7014792
• Product Code: POE
• UDI-Device Identifier: 05050474761766
• UDI-Public: (01)05050474761766(17)250422
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 04/22/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU185
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female