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

Model Number SN60WF

Device Problems Break (1069); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that intraocular lens crashed in the paracentral region, evaluated in the transoperative time with a microscope, when the lens was already intraocular.Therefore, proceeded to cut and remove the lens.Additional information has been requested and received.

Event Description

Additional information has been received and when the surgeon was going to implant the lens and realized that the haptic was broken.

Manufacturer Narrative

Correction: on initial mdr the product code of 2292 was an error.It should have been reported 1069 on the original mdr.The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the gusset area (returned).The other haptic was torn (still attached) in the gusset area.The optic was torn/split/cracked and cut into pieces, typical of insertion and removal.The file indicated the use of a qualified viscoelastic.The associated cartridge and handpiece were not provided.It is unknown if qualified products were used.Lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.Based on observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15770005
• MDR Text Key: 305335948
• Report Number: 1119421-2022-02389
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093221
• UDI-Public: 00380655093221
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 15446419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION HANDPIECE; DISCOVISC OVD; UNSPECIFIED OVD
• Patient Age: 79 YR
• Patient Sex: Female