MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60AC

Device Problems Break (1069); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested.(b)(4).

Event Description

A pharmacist reported that during a cataract extraction surgery, the surgeon was unable to use a competitor's lens due to "argentina flag syndrome." he requested a monofocal lens but it became stuck in the injector and a haptic broke.There was not a suitable back up lens, so the patient was left aphakic and given time to stabilize before going back to surgery for the lens implantation.Additional information was requested.

Manufacturer Narrative

The product was returned.Solution is dried on the lens.Haptic damage was observed.The customer indicated the use of a qualified cartridge and a non-qualified viscoelastic.Cartridge product history record were reviewed and the documentation indicated the product met release criteria.Reported broken haptic was observed.The root cause for the haptic damage may be related to a failure to follow the dfu.The file indicates the use of a non-qualified viscoelastic.Due to varying material properties, the use of non-qualified viscoelastic may result in lens delivery difficulties or product damage.Report of lens stuck in the injector could not be verified because the lens was returned in the lens case.(b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 7532223
• MDR Text Key: 108853846
• Report Number: 1119421-2018-00643
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.235
• Device Lot Number: 12544936
• Other Device ID Number: 00380652552592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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
• Treatment: COMPETITOR OVD; MONARCH B CARTRIDGE
• Patient Outcome(s): Other
• Patient Age: 72 YR