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

Model Number MTA3U0

Device Problems Product Quality Problem (1506); Material Too Rigid or Stiff (1544)

Patient Problems Inflammation (1932); Intraocular Pressure Increased (1937); Blood Loss (2597)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Complaint history and 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.Root cause has not been identified.This is a pmma hard lens model and is not foldable.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported when using intraocular lenses (iols) of this model, they seem 'stiff' and of low quality compared to other manufacturers.This seems to cause complications for the patients following surgery such as bleeding from the iris, increase in intraocular pressure (iop), and inflammations.Additional information was requested and received reporting that at least 10 patients have been affected, possibly more.The haptics on the lenses are 'hard' which caused bleeding in the eye.Some patients have experienced eye infections which were treated at the hospital.

Manufacturer Narrative

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

• Brand Name: ANTERIOR CHAMBER PMMA 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 ; 8175514979
• MDR Report Key: 9806934
• MDR Text Key: 182756860
• Report Number: 1119421-2020-00412
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: P880087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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