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

Model Number SA60AT

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Vitreous Floaters (1866); Hemorrhage/Bleeding (1888); Visual Impairment (2138); Capsular Bag Tear (2639)

Event Date 07/01/2021

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

Event Description

A consumer reported that following an intraocular lens (iol) implant procedure, the patient stated that, iol had broken haptic and is subluxate in the bag.The lens shifts in the eye causing bleeding and excessive floaters and lack of vision.The patient stated that her vision was great before lens dislocated.Patient states it occurred about a year and a half ago, she went to emergency and was sent home with no resolution.She has pre-existing granular dystrophy of the cornea.She sees 2 cornea specialists and has also seen a retinal specialist.No one has said anything about her lens and has been unable to see the lens.Recently, she had the granular dystrophy removed, but even at post op, no comments were made about her iol that she strongly feels has a broken haptic and is subluxate in the bag.Additional information has been requested.

Event Description

Additional information has been received and stated that,one haptic has broken off and capsular bag is gone.Broken haptic has torn up the broken bag.Cataract surgeon is planning to do surgery and then plans to insert a new lens at that time and a possible vitrectomy.Also consumer stated that lens is not floating, it is hanging in there on one side.As per the consumer there was no trauma that she is aware of, there has been no reason for lens breaking/dislodging.

Manufacturer Narrative

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

• Brand Name: ACRYSOF 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: 16215446
• MDR Text Key: 307800779
• Report Number: 1119421-2023-00183
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652555814
• UDI-Public: 00380652555814
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2007
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.205
• Device Lot Number: 695465
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETAZOLAMIDE QID; BRIMONIDINE BID
• Patient Outcome(s): Other
• Patient Sex: Female