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

Model Number DCB00

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

Sections a-2 patient age and date of birth, a-4 patient weight, and a-5 patient race: unknown/asked information unavailable.Section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section h3-other (81): 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.An attempt was made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the pre-loaded intraocular lens (iol) haptics were sticky during product handling.There was no patient injury, however additional maneuvers were required to position the iol during the surgery because the iol was difficult to manipulate.Information regarding the additional maneuvers was not provided.There was no incision enlargement, no suture(s), and no vitrectomy.Patient outcome post-procedure was reported as good condition.The suspect iol is not available for return as it was implanted into the patient's operative eye.No further information is available.

• 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: 17295605
• MDR Text Key: 318778114
• Report Number: 3012236936-2023-01758
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636149
• UDI-Public: (01)05050474636149(17)251209
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Hispanic