MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ACRYSOF IQ ASPHERIC IOL, SN60WF, SIZE 23.5D; INTRAOCULAR LENS

Model Number SN60WF +23.5D

Device Problems Positioning Problem (3009); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Lens delivered to sterile field, upon opening the protective lens case, the scrub rn noted that the lens was sitting off to the side up against the inner wall of the case and one of the haptics looked to be in the slot where the case fits together.I asked the surgeon to look at the lens under the microscope to make sure the haptic wasn't damaged,.It was then that he noted there was a tear in the body of the lens itself.This lens was removed from surgical field and a new lens was opened.

• Brand Name: ACRYSOF IQ ASPHERIC IOL, SN60WF, SIZE 23.5D
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 12323968
• MDR Text Key: 266654452
• Report Number: 12323968
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF +23.5D
• Device Catalogue Number: SN60WF +23.5D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2021
• Device Age: 0 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 50