MAUDE Adverse Event Report: ALCON RESEARCH, LLC. CLAREON; INTRAOCULAR LENS

Device Problems Break (1069); Crack (1135); Product Quality Problem (1506); Scratched Material (3020)

Patient Problem Failure of Implant (1924)

Event Date 08/04/2022

Event Type  Injury  

Event Description

Multiple eye surgeons are reporting cracking, scratches and haptic breaking of clareon intraocular lens during implantation/insertion for cataract surgery affecting multiple patients.There are two (2) incidences identified for broken haptics and four (4) cracked/scratched incidences of the intraocular lens.Fda safety report id# (b)(4).

• Brand Name: CLAREON
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 15418792
• MDR Text Key: 299958807
• Report Number: MW5112018
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White