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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported that a patient experienced halos/glare in their left eye post a yttrium aluminum garnet (yag) procedure.Surgeon was not certain if there was a correlation between the newly implanted intraocular lens (iol) and the yag procedure performed after implantation.Account indicated that it was not clear if the yag was performed proactively as part of their process or if it was done to treat the symptoms of halos/glare.At that time the implant date and iol serial number were not provided.The lens remained implanted with no plans to exchange the iol.Further information received on 5/6/2022 provided that during their last post-operative visit on (b)(6) 2022 the patient was complaining of blurry vision, difficulty driving at night, glare/halo around lights, and issues with depth perception especially with intermediate vision.The patient indicated being temporarily impaired and the visual issues significantly affect her daily activities.Account provided that the patient had the iol eyhance implanted in (b)(6) 2021, then yag was performed on (b)(6) 2021 as posterior capsule opacification (pco) was observed.The post-operative vision was provided as -20/25.Surgeon recommended an iol exchange or a consult with an optometrist for sclaral/hard contact lens fitting to correct residual 1.00 diopter of cylinder.The lens remains implanted.No further information was provided.
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).The lens remains implanted.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, 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.(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.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: 14569828
• Report Number: 3012236936-2022-01420
• Device Sequence Number: 6177116
• Product Code: HQL
• UDI-Device Identifier: 05050474731622
• UDI-Public: (01)05050474731622(17)240609
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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: 06/09/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0135
• 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: 05/06/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic