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)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient had reported to the u.S.Food and drug administration of an intraocular lens (iol) implant that had worsened symptoms and had caused new problems.The patient stated that the problems caused by this iol have not abated since implant.Glare is significantly worse.Oncoming headlights now appear as large triangles with radiating light.Constant flickering at left peripheral - like have a strobe light in her eye.Fields of white, i.E.Lamps, white paper (especially grids) have black dots dispersed throughout, as well as glare.It was noted that the symptoms have remained constant since implant.The patient stated that the doctor initially thought of prescribing medicine for glare.However, prior testing at mayo clinic on the patient ability to process medication indicated a high likelihood that she would experience side effects and contraindicated the use of medication for this issue.No surgical interventions have been required and the patient noted that since she learned of known problems with the lens more than six months after surgery, she was told that replacement of the iol would significantly increase the risk that the patient would lose her sight in this eye altogether.The patient last saw her doctor in (b)(6) 2023 and was told that a small cohort of patients with this lens was experiencing the same/similar problems and no one knew why.The patient indicated that reading and use of screens are significantly more difficult due to glare and black dots.Ability to use spreadsheets is impaired.Ability to drive at night has been curtailed.The patient mentioned that before the surgery, she had a cataract with some glare.No further information was provided.
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable as the device remains implanted.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed no other complaints were received for this production order number.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Section h6: health effect - clinical code: 2140 glare-persistent, 2140 visual disturbance- dysphotopsia-persistent 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: 19640981
• Report Number: 3012236936-2024-000183
• Device Sequence Number: 8673563
• Product Code: HQL
• UDI-Device Identifier: 05050474731929
• UDI-Public: (01)05050474731929(17)240503
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2024

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: 05/03/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0280
• 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: 06/18/2024
• Initial Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White