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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dib00 intraocular lens was implanted.The patient is essentially plano and 20/20 in each eye and happy that he did surgery but persistently bothered a 360 degree mid peripheral halo/distortion effect in each eye.It goes away with sunglasses.The patient was also bothered by artificial lighting in any scenario, natural light seems to be ok.Additional information stated that patient had midperipheral 360 degree distortion, blurriness around the edges of things, light sensitivity with artificial and indoor lighting and daily activities are significantly affected.Patients pre op best correced visual acuity (bcva) was 20/20 ou, post-op uncorrected and best corrected visual acuity, post op vasc was 20/25 and 20/20, bcva was 20/20 ou.Upon further follow up, it was informed that patient had repeated short treatment with prednisolone phosphate/bromfenax combination drop tid x 1 week, then twice a day for 1 week (no apparent effect).Patient has persistent symptoms, recommended trial of vuity but not clear if patient has picked up, due back in clinic at the time of this report.No other information was provided.
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section h3: other 81: the device was not returned for evaluation as the lens remain implanted in the eye.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 - clinical code: 2140- hm-photophobia/increased light sensitivity-persistent : photophobia.Section h6: health effect - clinical code: 2140- hm-visual disturbance- dysphotopsia-transient : visual impairment.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: 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: 16748013
• Report Number: 3012236936-2023-00918
• Device Sequence Number: 12893800
• Product Code: HQL
• UDI-Device Identifier: 05050474731967
• UDI-Public: (01)05050474731967(17)240114
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 01/14/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0300
• 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: 03/18/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White