MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problems Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.The product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported a patient who underwent cataract surgery with intraocular lens (iol) implant of the left eye.During the surgery a crease in the lens was noted without obvious abnormality to the lens.During viscoelastic removal there was a white cord from one point to the center of the cornea; the microscope was focused on the cornea so the actual situation could not be judged.It was noted that the cord was not in the same plane with the fold of the lens.Postoperatively the patient complained o occasional cord like occlusion in he eye and the surgeon noted a cord like yellow attachment between the lens and the posterior capsule to the center of the lens.The surgeon performed a suction operation and after separating the intraocular lens and the capsule in the operating room but the lens adhered closely to the anterior and posterior capsule.The separation of the lens and capsule was not successful.In further follow up the patient was noted to have conjunctival congestion and atrial scintillation.The lens was in the right and middle position.There was a yellow ribbon from a point on the posterior surface of the lens to the center of the lens.The narrow slit light band was not smooth and uneven at the ribbon on the posterior surface of the lens.

Manufacturer Narrative

Additional information provided in h.3, h.6, and h.10.The lens and reported foreign material were not returned for evaluation.Photos and a video were provided.These were reviewed several representatives and the reviews are summarized.The provided photos show an unknown opaque material that appears to be located on the posterior surface of the implanted iol.This material may appear ¿yellow¿ depending on the light source used.Review of the provided video did not show the lens or cartridge preparation or the initial advancement.Both haptics appeared to be in acceptable positions.The plunger is not advanced far enough to release the trailing haptic.The trailing haptic is pulled back into the incision when the cartridge is removed from the eye.An instrument is used to push the trailing haptic into the eye.Loose grainy particles are observed floating in the front of the eye as the lens is unfolding (possibly dried ovd).As the lens unfolds, two fold lines are observed on the optic.There also appears to be a foreign material near the center of the lens on the posterior surface.No further determination can be made from the video.A qualified cartridge and handpiece were indicated.The indicated viscoelastic is not qualified for use with the iol/delivery system combination.Iol product history records were reviewed and documentation indicated the product met release criteria.A root cause for the reported events could not be determined.The product and foreign material were not returned for evaluation.The photo and video review showed fold lines and what appeared to be a foreign material on the posterior surface of the implanted iol.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11215063
• MDR Text Key: 228215558
• Report Number: 1119421-2021-00119
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFC270
• Device Lot Number: 12703414
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIWEI; MONARCH III C CARTRIDGES, 8065977762, HWV; MONARCH III IOL DELIVERY SYST, 8065977773, APD; AIWEI; MONARCH III C CARTRIDGES, 8065977762, HWV; MONARCH III IOL DELIVERY SYST, 8065977773, APD
• Patient Outcome(s): Required Intervention