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

Model Number DCB00

Device Problem Difficult to Insert (1316)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/31/2023

Event Type  Injury  

Event Description

It was reported the dcb00 model intraocular lens (iol) was placed in the patient¿s ocular dexter (right eye) without issue.When the surgeon went to irrigation/aspiration (i/a) and remove the last of the remaining healon in the anterior chamber, the bag became unstable and the iol shifted.The surgeon felt the bag was not strong enough to hold the iol in place so the iol was removed and a 3-piece za9003 22.0 diopter iol was inserted.The surgeon stated that the need to remove the iol was not a product issue but a weak zonule issue.There was no incision enlargement, no medical or surgical intervention, no suture(s), and no vitrectomy.The patient left the operating room in stable condition.The iol is unavailable for return.Alcon bss was used at room temperature, it was introduced from the cartridge canopy, and no additives were used.The average dwell time is under one minute.The iol is advanced just enough to give ½ turn of the inserter.Surgical technician performs the initial movement and the first twist.Once the lens passes the dwell position, the advancement is uninterrupted and slow complete turns are being made during lens advancement.No further information is available.

Manufacturer Narrative

Additional information: section d-6a date implanted: not applicable as the iol was removed and replaced during the same procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the same procedure, therefore not explanted.Section h3-81: the device was not 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.Section h-6 health effect - clinical code: 4581 device decentered or device dislocation and eye anatomy issue.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: 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: 18179353
• MDR Text Key: 328621288
• Report Number: 3012236936-2023-02930
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636132
• UDI-Public: (01)05050474636132(17)260227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALCON BSS.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female