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

Model Number DIB00

Device Problems Operating System Becomes Nonfunctional (2996); Material Split, Cut or Torn (4008)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: device not implanted.If explanted, give date: device not implanted, therefore not explanted.Telephone number:(b)(6).The intraocular lens (iol) was not returned for evaluation as it was discarded; 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 has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the lens is defective and that the material was discarded.Through follow up it was confirmed that the implant was damaged during the injection.When screwing in the plunger, before insertion into the incision, the surgeon felt an abnormal resistance; stopped the injection and took another preloaded implant.After the operation, the surgeon took out the implant of the defective injector and found, after analysis under the microscope, that the implant was "torn" on the edge.The surgeon thinks that the plunger was not in the axis of the implant, which hindered the injection and finally damaged the implant.The issue was noticed before the implant was injected into the eye so there was no harm to the patient.No further information was provided.

• 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: 15611454
• MDR Text Key: 306984650
• Report Number: 3012236936-2022-02607
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655386
• UDI-Public: (01)05050474655386(17)250129
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/14/2022

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
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00I0190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2022
• 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