MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AUL0T0

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A physician reported that during a cataract surgery with an intraocular lens (iol) implant, the iol was implanted into the patient's eye with the trailing haptic folded (in a state of remaining in the injector), and rupture of the posterior capsule occurred.The surgery was completed without product replacement.He/she tried to remove the iol after implantation, but the folded haptic caused the rupture of the posterior capsule.The iol remains in the capsule and the position of the iol was not bad.Additional information was provided indicating that the posterior capsule was not ruptured and the cornea was completely transparent with no edema before the iol was inserted.When the iol was inserted in the capsule, the viscoelastic was removed and at that time the iol haptics broke.While an attempt was made to remove the iol, the broken iol caused the posterior capsule to rupture.If the iol was normal with no issue, the event would not have occurred; causality was related per the surgeon.Additionally, the vitreous body moved inside the anterior chamber, the iol moved upward and it hurt the back of the cornea.Described as corneal edema/ iol dislocated downward.Completing the surgery without iol removal was safer per the surgeon.

Manufacturer Narrative

Additional information was provided in h.3., h.6.And h.10.Evaluation summary: the product was not returned.Information in the file indicated that the lens remained implanted.A photo of the lens while in the eye was provided in the file.This image shows clearly a broken haptic in the outer gusset area.The other haptic area cannot be viewed from the angle in this image.There was a small dark area observed on/over the edge of the optic which may be damage.A final determination for the other haptic and for the optic cannot be determined from this image.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.Based on the image attached in the file, a broken haptic was observed.The root cause of the reported broken haptic may be related to a failure to follow the directions for use (dfu).A non-qualified viscoelastic was indicated.The use of non-qualified viscoelastics is considered a failure to follow the dfu for this intraocular lens and with this preloaded delivery system and is not recommended under any circumstance.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10901226
• MDR Text Key: 218179712
• Report Number: 1119421-2020-01774
• Device Sequence Number: 1
• Product Code: KYB
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: AUL0T0
• Device Lot Number: 12748538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPEGAN HI; OPEGAN HI
• Patient Outcome(s): Other
• Patient Age: 72 YR