MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF NATURAL TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN60T3

Device Problem Material Opacification (1426)

Patient Problem Visual Disturbances (2140)

Event Date 02/09/2018

Event Type  Injury  

Event Description

A health care professional reported that approximately nine years following a cataract removal with intraocular lens (iol) implant procedure, the iol was observed to be opaque.There was no reported harm to the patient.The patient will return for re-evaluation in three to four months.Additional information has been received and stated that there was reduction in patients quality of vision.The surgeon iol exchange would be beneficial to the patient but not yet explanted at the time of reporting.

Manufacturer Narrative

This product malfunction was originally reported under an alternative summary report.Additional information has been has been provided which prompts a different assessment.As the alternative summary report has been revoked, the updated information is being sent via this 3500a report.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was retuned on a peel sticker, inside a small specimen cup.Blood was dried on the lens.One haptic was broken in the gusset area (not returned).The optic was torn/split/cracked and cut into pieces, typical of insertion and removal.The lens was cleaned with klrp (klotho-related protein) for further evaluation.The lens appears clear.Power and resolution testing could not be conducted due to the extensive optic damage.The product investigation could not identify a root cause for the reported complaint.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received and stated that, the iol was explanted in a secondary procedure.

• Brand Name: ACRYSOF NATURAL TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13017876
• MDR Text Key: 282335811
• Report Number: 1119421-2021-02406
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: SN60T3
• Device Catalogue Number: SN60T3.230
• Device Lot Number: 10848313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention