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

Model Number	DCB00
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable.There is no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There is no indication the lens was implanted.Therefore, not explanted.Section h6- health effect - impact code: 4625 used to capture the incision enlargement.Section h6- health effect - clinical code: 4581 used to capture the incision enlargement.Section h3, device evaluated by manufacturer: the device has not been 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.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was not able to be implanted due to the incision size in the patient's right eye.The doctor inserted the cartridge tip into the eye.The incision may have been too small and it seemed the cartridge was inside the eye but it¿s difficult to confirm.Reportedly, the lens came out of the injector and pushed the injector back as the lens was being placed into the eye.When the doctor began to twist somehow the injector came out of the incision.The iol was not fully inserted and was caught in the incision.The iol was not fully inserted and was caught in the incision.The doctor carefully removed the iol from the incision using additional maneuvers.The issue may have been related to use error but it¿s difficult to say.The doctor had to switch to a backup dcb00 of the same diopter and widen the incision.The doctor said that it¿s impossible to say whether we send him a bad product or if it's human error.His incision was 2.3 mm (millimeter).The iol is a higher diopter 27.5 so he had to enlarge the incision to insert the lens.There were no adverse effects.The patient¿s pressure 1 day postop was 34 then went down to 13 later the same day when the doctor checked her.Reportedly, the patient is doing well.No further information was provided.

• 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: 20317559
• Report Number: 3012236936-2024-000264
• Device Sequence Number: 12679927
• Product Code: HQL
• UDI-Device Identifier: 05050474636231
• UDI-Public: (01)05050474636231(17)251110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000275
• 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: 09/24/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White