MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNA0T3
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, faulty lens was not folded properly.Additional information was requested and received.The lens was replaced with the unspecified lens (back up lens was used).There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Received photos shows an company device in a bag.The plunger is advanced to mid nozzle.The iol is advanced to between mid nozzle and wound guard, the leading haptic is straight, the trailing haptic is folded onto the optic.Based on our observation of the attached photo, straight leading haptic was observed.The presentation of straight leading haptics is addressed in the product instructions for use (ifu) where it is provided that delivery may proceed with caution and should be managed based on the outlined instructions.Straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated root cause factors may also include: use of a non-qualified viscoelastic or bss in the delivery system.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Excessive delay between device preparation and subsequent delivery resulting in the potential for haptic unfolding.Use of the delivery system at operating room temperatures outside of the recommended range of 18 °c (64 °f) to 23 °c (73 °f).Ovd should be allowed to come to operating room temperature over a 30 minute timeframe prior to use.Any of the above listed causes alone, or in combination, may create the reported event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3., h.6.And h.11.The product was returned for analysis and straight leading haptic was observed.The device was returned loose in the carton.The lock-out assembly has been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger and the lens are advanced into the mid nozzle.The plunger is at the trailing optic edge.The trailing haptic is folded onto the optic.The leading haptic is extended straight.Received photo shows an company device in a bag.The plunger is advanced to mid nozzle.The iol is advanced to between mid nozzle and wound guard, the leading haptic is straight, the trailing haptic is folded onto the optic.The plunger, lens and haptic positions are acceptable.The presentation of straight-leading haptics is addressed in the product instructions for use (ifu), where it is provided that delivery may proceed with caution and should be managed based on the outlined instructions.While straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated factors may also include: ¿use of a non-qualified viscoelastic or bss( balanced salt solution) in the delivery system.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.¿excessive delay between device preparation and subsequent delivery resulting in the potential for haptic unfolding.¿use of the delivery system at operating room temperatures outside of the recommended range of 18 °c (64 °f) to 23 °c (73 °f).Ovd should be allowed to come to operating room temperature over a 30 minute timeframe prior to use.Any of the above factors alone, or in combination, may lead to an event such as reported.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 19126161
• Report Number: 9612169-2024-00337
• Device Sequence Number: 12674485
• Product Code: MJP
• UDI-Device Identifier: 00380652398749
• UDI-Public: (01)00380652398749(17)270629(11)230701(10)25660203
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T3
• Device Lot Number: 25660203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 08/19/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 07/11/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown