MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; 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	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: patient weight and a5: ethnicity: unknown; requested but not provided.Section h3-other (81): the device was not returned for evaluation; 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.Section h6: health effect - impact code 2271 and health effect - clinical code 4581 are to capture sub-optimal results.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) that was implanted in the patient's left eye (os), is going to be explanted on (b)(6) 2023 due to excessive glare.It will be replaced with another johnson and johnson iol (eyhance dib00 model).Through follow-up, it was learned that that besides glare, the patient is also not happy with the visual acuity (va) in the os.The symptoms started on post-operative day one ((b)(6) 2023).The patient¿s pre-operative va os was uncorrected distance (dsc) 20/50-1, corrected distance (dcc) 20/25, near uncorrected (nsc) 20/70, near corrected (ncc) 20/30, brightness acuity test (bat) 20/30.The patient's post-operative va post-original implant in os was dsc 20/25 blurry, nsc j7 very blurry.It is unknown if the visual issues affected the patient's daily activities.No medical or surgical intervention for this issue has been performed yet.The patient is awaiting the iol exchange surgery.Additional information was received reporting that the iol exchange was performed on (b)(6) 2023.The iol exchange surgery operative report was provided.The patient¿s pre-operative checklist report for the iol exchange states that the patient wants near vision.The patient has allergies to sulfa, tremadol, and levaquin and the patient¿s left eye is non-dominant.The replacement dib00 +26.0 diopter iol was selected for -2.50 endpoint.The operative report from (b)(6) 2023, states that the procedure performed was left eye exchange of iol, left possible anterior mechanical vitrectomy, with pre and post-operative diagnosis of refractive error os.The indication for the procedure was noted as decreased visual acuity which is interfering with the patient¿s activities of daily living.The description of the procedure includes the surgeon's standard pre-operative, intra-operative, and post-op iol exchange surgery steps which were followed with no complications.No secondary surgical or medical interventions were performed.The patient was taken to the recovery room in a satisfactory condition.Follow-up in 24 hours.No further information was provided.
Additional Manufacturer Narrative
Correction: in reviewing initial mdr 3012236936-2023-02623, it was noticed that the event was originally coded as health effect - impact code 2271 - therapeutic response decreased and health effect - clinical code 4581 - appropriate term/code not available to capture sub-optimal results, however a more appropriate code to capture the refractive error event is health effect - clinical code 2138 - visual impairment.Therefore, this supplemental mdr is capturing this corrected information of removing the original code of 2271 and 4581 and replacing with 2138.The following sections have been updated accordingly: section h6: health effect - clinical code 2138 - visual impairment.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: 17971116
• Report Number: 3012236936-2023-02623
• Device Sequence Number: 17901311
• Product Code: POE
• UDI-Device Identifier: 05050474761834
• UDI-Public: (01)05050474761834(17)250726
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/24/2023

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: 07/26/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU220
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Race: White