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

Model Number SN60WF

Device Problem Folded (2630)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Lens did not unfold properly; concerned about memory in the haptic.A new lens was used to complete the procedure.The lens had patient contact but no patient harm.
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manufacturer response for alcon acrysoft lens, (brand not provided) (per site reporter).
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reported via phone.Waiting for rma.

• Brand Name: ACRYSOF
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 7337393
• MDR Text Key: 102348076
• Report Number: 7337393
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SN60WF
• Other Device ID Number: SN60WF 16.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1