MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number ICB00

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.If explanted, give date: not applicable, as the device remains implanted.Initial reporter telephone number: (b)(6).Device evaluated by mfr: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that one of the haptics was thin, especially when the haptic was unfolded.There was a haptic damage.The iol was fully implanted into the patient's eye and it stayed well-centered even after rotation and removal of ovd.Thus, the iol was left in the patient's eye.There was no delay in treatment or other interventions provided.No further information was provided.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15887934
• MDR Text Key: 307696508
• Report Number: 3012236936-2022-02906
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610804
• UDI-Public: (01)05050474610804(17)270128
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/30/2022

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: ICB00
• Device Catalogue Number: ICB00I0225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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