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

Model Number SN6AT5

Device Problem Break (1069)

Patient Problem Visual Impairment (2138)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Product history and batch 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.Attempts have been made to obtain additional information by email, phone and fax.A completed questionnaire was not received.(b)(4).

Event Description

A consumer reported that during an intraocular lens (iol) implant procedure, the lens broke and was removed from his eye and replaced with another lens.He indicated that his vision was decreased.In a follow up, the surgeon reported that the lens broke during insertion and was cut and removed from the eye and another lens was implanted instead.Due to the manipulation of the first iol having to be removed, the patient is now recovering from corneal edema which is contributing to decreased vision.The surgeon reported that the edema is resolving day by day.Additional information was requested.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the consumer indicated that the corneal edema and decreased vision have not resolved.The patient has seen a corneal specialist who has suggested that a partial corneal transplant be considered.The patient is contemplating the transplant intervention.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the consumer in the format of medical records.The consumer reported blurry vision in all postoperative visits.During the one day postoperative visit, the consumer had increased intraocular pressure (iop), which was treated with multiple glaucoma drops.The patient was also treated with a sodium chloride preparation.

Manufacturer Narrative

(b)(4).

Event Description

The consumer/patient was diagnosed as having pseudophakic bullous keratopathy by a corneal specialist approximately 3 months after the initial reported event.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5214582
• MDR Text Key: 30901450
• Report Number: 1119421-2015-06558
• Device Sequence Number: 1
• Product Code: MJP
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.240
• Device Lot Number: 12389641
• Other Device ID Number: 00380652251075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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: 82 YR