MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AU00T0

Device Problems Defective Component (2292); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A nurse reported that during an intraocular lens (iol) implantation procedure, there was challenges with the plunger but surgeon decided to use the device anyway.The device was prepared normally according to instructions and pushed plunger forward and noticed that plunger was sliding on top of the lens.The technician pulled the plunger back and asked the surgeon to check the lens.The surgeon inspected the lens and said the lens could still be used.The surgeon pushed plunger forward and this time plunger pushed the lens forward as it should.The lens was placed in the eye but the trailing haptic of the lens was not properly folded inside the lens but was stuck between the plunger and the tip of the delivery system.Lens was freed from the delivery system with forceps.The lens remained undamaged and the lens was fitted to the eye.The surgeon had used forceps was used to remove the haptic from between the injector tip and plunger.The lens remained undamaged and the lens was fitted to the eye using an auxiliary instrument.The is no patient harm was reported.No further information available.

Manufacturer Narrative

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

Event Description

A nurse reported that during an intraocular lens (iol) implantation procedure, there was challenges with the plunger but surgeon decided to use the device anyway.The device was prepared normally according to instructions and pushed plunger forward and noticed that plunger was sliding on top of the lens.The technician pulled the plunger back and asked the surgeon to check the lens.The surgeon inspected the lens and said the lens could still be used.The surgeon pushed plunger forward and this time plunger pushed the lens forward as it should.The lens was placed in the eye but the trailing haptic of the lens was not properly folded inside the lens but was stuck between the plunger and the tip of the delivery system.Lens was freed from the delivery system with forceps.The lens remained undamaged and the lens was fitted to the eye.The surgeon had used forceps was used to remove the haptic from between the injector tip and plunger.The lens remained undamaged and the lens was fitted to the eye using an auxiliary instrument.The is no patient harm was reported.No further information available.

Manufacturer Narrative

We are unable to determine the root cause for the reported complaint "plunger override.".Sample was not returned for evaluation.Plunger override may occur: if the lens has become misaligned in the lens bay during the manufacturing process.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to override the lens.If the operating room temperature is too high 23°c / 73° f lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.The reported trailing haptic issues cannot be confirmed, however they most likely occurred due to re-use of the lens post plunger override observation.Ifu (instructions for use) does not instruct to re-use the device.In addition to this, the ifu instructs: "visually inspect the lens to determine the position of the leading and trailing haptics.Verify that the plunger is in contact with the trailing optic edge." based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13504369
• MDR Text Key: 285404695
• Report Number: 9612169-2022-00055
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394734
• UDI-Public: 00380652394734
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: AU00T0
• Device Lot Number: 25138732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AUXILIARY INSTRUMENT; FORCEPS; UNSPECIFIED DISCOVISC