MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON CLAREON; INTRAOCULAR LENS

Model Number SY60WF 14.0D

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  Injury  

Event Description

Trailing optic edge and trailing haptic near junction.Fda safety report id# (b)(4).

• Brand Name: ALCON CLAREON
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 15493668
• MDR Text Key: 300711223
• Report Number: MW5112269
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY60WF 14.0D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic