MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60AT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Vitreous Floaters (1866); UGH (Uveitis-Glaucoma-Hyphema) Syndrome (2115); Discomfort (2330); Capsular Bag Tear (2639)

Event Date 04/22/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation; the device is currently implanted.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A surgeon reported a patient who has uveitis-glaucoma-hyphema (ugh) syndrome after cataract surgery with an intraocular lens (iol) implant.During the surgery, the patient had a posterior capsule tear.Additional information provided reports the patient is experiencing glare, ocular discomfort, floaters, and flashes.The patient states the eye 'feels sore'.It appears there is a 'hair' or string in line of peripheral vision.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6773377
• MDR Text Key: 82031806
• Report Number: 1119421-2017-01012
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.195
• Device Lot Number: 12338802
• Other Device ID Number: 00380650130297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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): Other
• Patient Age: 80 YR