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

Model Number MA60AC

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problem Capsular Bag Tear (2639)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure the surgeon indicated that the leading haptic may have been deformed causing a posterior capsular tear with iridodyalisis.The surgeon attempted to position the lens out of the damaged bag, but on postoperative day one, the haptic was found to be in front of the iris.Six days later the patient was returned to surgery and the haptic was repositioned into the sulcus area between the iris and the anterior capsular rim.One day after the repositioning, the surgeon noted that the haptic was stuck in the iris, and the lens body had fallen into the vitreous.Three days later the patient was taken back to surgery by another surgeon who explanted the fallen iol and implanted another lens by scleral fixation.In a follow up, the surgeon indicated that the current lens is stable, but the patient's vision has not improved yet due to corneal folds.

Manufacturer Narrative

The video was provided and reviewed.The cartridge and lens preparation were not shown.The lens is visible at the nozzle entry area before advancement into the eye.The lens appears of be folded correctly.No damage is observed to the haptics at this position.The lens is advanced into the eye with device rotation from the nozzle entry area.The leading haptic is visible as the lens is delivered.No leading haptic damage can be observed.The cartridge tip is removed from the eye before release of the trailing haptic.The trailing haptic is pulled to the right (against the curve) outside of the eye using the plunger.The lens is rotated clockwise with an instrument at the trailing haptic gusset area, which pulls the trailing haptic into the eye.The lens appears off center.An instrument is used to adjust the lens using the optic surface and the trailing haptic gusset area (rotated clockwise).Lens still appears off center.Additional ovd is added.Lens is adjusted with an instrument (closer to centered).Haptics are near the 9 and 3 o¿clock position.The video ends at this point.The explanted lens was returned loose in a plastic bag.Viscoelastic is observed on the lens.The lens has been cut into two pieces.One haptic is pinched and bent distal area with small fractures.The second haptic has a small nick on the outer surface near the gusset area with a fracture.The haptic damage was not observed on the provided video.This damage may have occurred during the removal process or during the surgery to reposition the lens which occurred on (b)(6) 2019.The cartridge used in qualified with the iol.The indicated handpiece is not qualified for the lens/cartridge combination used.The root cause for the reported events could not be determined.It was indicated surgery was completed by ¿out of the bag fixation¿.Per the dfu: these lenses are intended for placement in the capsular bag.Review of the provided video does not appear to show haptic damage as the lens is delivered or positioned after delivery.The lens does appear off center and is maneuvered several times with an instrument.The instrument is placed on the optic and at the trailing haptic gusset area.The video ends with the undamaged lens in the capsular bag.The reported ¿out of bag fixation¿ was not shown.The returned explanted lens had damage typical of a removal.The lens was cut into two pieces.One haptic is pinched and bent distal area with small fractures.The second haptic has a small nick on the outer surface near the gusset area with a fracture.The haptic damage was not observed on the provided video.This damage may have occurred during the removal process or during the surgery to reposition the lens which occurred on (b)(6) 2019.Although an issue was not observed on the provided video of the surgery, the handpiece indicated is not qualified for the lens/cartridge combination used.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8892426
• MDR Text Key: 154270975
• Report Number: 1119421-2019-01300
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: MA60AC
• Device Catalogue Number: MA60ACQ240
• Device Lot Number: 12643013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9045SP HP; MONARCH B; AE-9045SP HP; MONARCH B
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR