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

Model Number SN6AT4

Device Problem Scratched Material (3020)

Patient Problem Visual Impairment (2138)

Event Date 05/15/2015

Event Type  Injury  

Event Description

A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision and the iol was scratched.The iol was exchanged for the same lens model and power.Additional information was provided by the nurse, who reported that the scratch on the iol blurred the patient's vision.The event resolved with treatment.

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information by phone and fax.A completed questionnaire was received.(b)(4).

Manufacturer Narrative

Additional information was provided.Evaluation summary: the product was returned for analysis; the reported complaint could not be verified, the optic is too damaged to conduct a check for the optical resolution or the diopter of the lens.Solution was observed on the returned product.The product was returned and damaged was observed.The lens was taped on a piece of foam.Additional information was provided, which indicated an approved cartridge was used with a handpiece with an unapproved viscoelastic.There was not enough information provided to conduct a review on the cartridge lot.The root cause could not be determined for the patients poor vision; however, the optic was scratched.While we are unable to determine the root cause of the damage, our observation reasonably suggests that this is not manufacturing related.Due to the condition of the returned sample, the damage is most likely related to customer handling.In addition, an unapproved viscoelastic was used which is a failure to follow the directions for use.The manufacturer internal reference number is: (b)(4).

• 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: 4869626
• MDR Text Key: 6046468
• Report Number: 1119421-2015-05665
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.235
• Device Lot Number: 12330662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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
• Treatment: PROVISC; MONARCH III HANDPIECE; BSS 500ML WITH VANCOMYCIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 75