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

Model Number SN6AD1

Device Problems Application Program Problem: Power Calculation Error (1473); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A nurse reported that following a cataract extraction with intraocular lens (iol) implant procedure, the iol was exchanged due to a power miscalculation.Additional information was provided by the surgeon, that preoperative measurements concurred on the patient¿s original iol power selection, so measurement devices are not specifically to blame; more likely, the iol has a different elp (effective lens position) than was predicted.Further information was provided that the patient's prognosis is good.

Manufacturer Narrative

This supplement is being filed to correct the value to adverse event and product problem.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Product evaluation: the lens was returned in a specimen cup.Solution is observed in the container and on the lens portions.One haptic is broken-gusset and distal area (distal tip not returned).The optic is cut into three pieces.Power and resolution could not be verified due to the optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and viscoelastic were indicated.Cartridge 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 for the reported "power miscalculation".Power and resolution testing could not be conducted due to the optic damage.(b)(4).

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7673970
• MDR Text Key: 113550056
• Report Number: 1119421-2018-00890
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: SN6AD1
• Device Lot Number: 12436396
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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: CENTURION HANDPIECE; MONARCH D CARTRIDGE; ORA; PROVISC
• Patient Outcome(s): Other; Required Intervention