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 Code	Visual Disturbances (2140)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported that a patient who received a multifocal symfony intraocular lens (iol) is visually seeing great with distance vision being 20/20 and j2 for nearby.The patient's vision per-operative was 20/200 and post-op (after cataract surgery) was 20/20.Reportedly, the patient fully recovered.However, the patient is extremely unhappy with the glare associated with this lens and cannot tolerate it.That the patient is so unhappy that the doctor is discussing doing an removal & replacement (r&r) and replacing the lens with a non-johnson & johnson iol.Additional information received indicated that the patient's daily activities were significantly affected.On (b)(6) 2024, when the doctor tried to remove the lens during a follow-up procedure, they encountered significant scar tissue around the lens, which made it impossible to remove.The cause of this scar tissue formation is unclear and it is unknown why the patient's body reacted like that.It was confirmed that the patient is not debilitated and is fine.Before the attempted lens removal, the patient¿s uncorrected visual acuity was 20/20.After the procedure, the patient's vision dropped to 20/100 uncorrected.The doctor thinks the patient's vision will go back to 20/20 after the swelling goes down.No surgical interventions performed during this procedure.The doctor has decided not to attempt further lens removal and has left the lens in place.The patient is on standard post-operative medication and no medications outside of normal treatment has been prescribed.The patient initially underwent cataract surgery without complications, and it was confirmed there were no issues such as incision enlargement, sutures, vitrectomy or capsule tears during the procedure.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 po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 20929030
• Report Number: 3012236936-2024-000335
• Device Sequence Number: 20930343
• Product Code: POE
• UDI-Device Identifier: 05050474761872
• UDI-Public: (01)05050474761872(17)250422
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 04/22/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU240
• 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: 11/19/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White