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 03/03/2023

Event Type  Injury  

Manufacturer Narrative

Date explanted: not applicable as the iol remains implanted, therefore not explanted.Initial reporter telephone number: (b)(6).The device was not returned for evaluation as it remains implanted in the patient¿s ocular dexter (right eye).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.Health effect - impact code: 4625 sutures and vitrectomy.Medical device problem code: 4012 haptic stuck to haptic and haptic stuck to optic.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported after implantation, the dcb00 intraocular lens (iol) loops were strongly adhered, requiring sequences of risky intraocular maneuvers to separate them.Additional information was received clarifying the haptic held to the haptic and adhered to the face anterior face of the optical zone.Insertion of the lens manipulator klugen hook by the paracentesis associated with the seizure of the handles with the forceps utrata and execution of movement of the opposing force.There was no incision enlargement and no serious patient injury however suture(s) and vitrectomy were required.Iol is not available for return as it remains implanted in the patient¿s ocular dexter (right eye).

• 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: 16631740
• MDR Text Key: 312167678
• Report Number: 3012236936-2023-00768
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636125
• UDI-Public: (01)05050474636125(17)251206
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: DCB0000220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White