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

Model Number ICB00

Device Problems Break (1069); Inaccurate Delivery (2339)

Patient Problem Eye Injury (1845)

Event Date 04/19/2023

Event Type  Injury  

Event Description

It was reported that the intraocular lens (iol) haptic broke midway during inserting into patient's eye.Lens was partially inserted and removed.There was a delay of 20 minutes to the procedure.Medication was prescribed but the reason is unknown.No further information was provided.

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.Implant date: not applicable, as lens was not implanted.Explant date: not applicable, as lens was not implanted.Initial reporter last name: unknown/not provided, as information was asked but it was not provided.Email address: unknown/not provided, as information was asked but it was not provided.Initial reporter telephone number: (b)(6).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.

Manufacturer Narrative

Section d9: device available for evaluation: yes, date returned to manufacturer: 17 may 2023, section h3: device evaluated by manufacturer: yes.Device evaluation: the intraocular lens (iol) was received cut in half inside of the daisy wheel.The lens was cleaned and visual inspection under magnification found one haptic is detached and missing, and damage to the optic were observed.The complaint issue was not identified during photo and product evaluation.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 16924938
• MDR Text Key: 315171446
• Report Number: 3012236936-2023-01211
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610637
• UDI-Public: (01)05050474610637(17)270808
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 06/29/2023

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: ICB00
• Device Catalogue Number: ICB00I0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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