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

Model Number SN60T4

Device Problems Device Damaged Prior to Use (2284); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2011

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.(b)(4).

Event Description

A health professional reported that before an intraocular lens (il) implant surgery, the lens was found to be defective (cloudy), additional information has been requested.

Event Description

New information received from the customer stating the lens will be removed.

Manufacturer Narrative

The original mdr submitted pma/510k date of 08-may-2019 was not correct.The correct pma/510k date should have been 06-may-2019.The manufacturer internal reference number is: (b)(4).

Event Description

Correction and clarification of the event.The defective (cloudy) lens was not discovered before the initial surgery as originally reported but several years after during a follow up visit.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 8612676
• MDR Text Key: 145354165
• Report Number: 1119421-2019-00688
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: SN60T4
• Device Catalogue Number: SN60T4.285
• Device Lot Number: 10863960
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 06/03/2019; 08/23/2019
• Supplement Dates FDA Received: 06/04/2019; 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1