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

Model Number DIB00

Device Problem Ejection Problem (4009)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h6- health effect - clinical code 4581: no code available (incision enlargement).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during injection of the preloaded intraocular lens (iol) it remained stuck in the incision as the patient was in pain and moved.The surgeon had to remove the implant with forceps, which was painful for the patient.The incision was enlarged and a delay in the procedure was caused.No further information was provided.

Manufacturer Narrative

Additional information: additional information was received and the following corresponding field is being updated: section b5 - describe event or problem: further follow up revealed that the lens was partially injected.The patient felt pain during the injection, probably due to the pressure exerted on the eye, and had to move, which forced the injector and the lens not to be fully injected but remain in the incision.Account indicated that part of it was inside the eye and the other part was outside the eye.All pertinent information available to johnson and 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: 18420998
• MDR Text Key: 331686489
• Report Number: 3012236936-2023-03298
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655430
• UDI-Public: (01)05050474655430(17)260802
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: DIB00I0215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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