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

Model Number SN6AT4

Device Problem Defective Component (2292)

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

Event Date 07/05/2018

Event Type  malfunction  

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.Additional information has been requested.(b)(4).

Event Description

A clinical manager reported an intraocular lens that the doctor felt like there was an edge on the lens.There was no information about patient contact.Additional information was provided by the clinical manager, who reported that during an intraocular lens (iol) implant procedure, upon inserting the lens, it had line.The defective lens was removed immediately and a new lens inserted.Per the doctor the patient had a hyphema but the patient will heal fine.The procedure was completed.There was no medical or surgical intervention required.

Manufacturer Narrative

Evaluation summary: the product was returned.Blood and solution is dried on the lens.A transparent fiber is adhered to the posterior side of the optic by dried solution.One haptic is bent in the gusset and distal area.This haptic also has a small split/crack in the gusset area which may have been interpreted by the customer as the reported complaint of ¿line on lens¿.The other haptic is broken in the gusset area (returned).The optic is cut into two portions, typical of insertion and removal.One cut optic portion has a large deep linear scrape mark on the posterior side of the lens near the edge.This damage may have been interpreted by the customer as the reported complaint of ¿line on lens¿.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a non-qualified cartridge.The customer indicated the use of an unspecified handpiece and a non-qualified viscoelastic.The cartridge product history record could not be reviewed because the facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause may be related to a failure to follow the directions for use (dfu).The file indicates the use of a non-qualified lens/cartridge combination.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7822732
• MDR Text Key: 118872816
• Report Number: 1119421-2018-01219
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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: 04/30/2022
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.310
• Device Lot Number: 12543010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• 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: 63 YR