MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number SY60WF

Device Problems Defective Device (2588); Material Split, Cut or Torn (4008)

Patient Problem Corneal Edema (1791)

Event Type  malfunction  

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.The complainant indicates the use of non-company as a viscoelastic, which is not qualified for use with company model, this is not a qualified company product combination.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, the haptic was found to be torn when the lens was implanted during surgery.The lens with the torn haptic was explanted and replaced with a new iol, and the surgery was completed.Additional information was received stating patient experienced corneal edema.

Manufacturer Narrative

Additional information was provided in h.3, h.6 and h.10.The product was returned for analysis and the reported complaint was observed.Intraocular lens returned crushed in intraocular lens case base.Solution is dried on the intraocular lens.One haptic is broken/torn and not returned, the other haptic is intact.The optic is torn/split-cut dividing the intraocular lens in three and scratched/marked-rejectable with fibers.Video shows intraocular lens implantation.The lens and device preparation is not recorded.The cartridge comes in the picture.The lens is advanced into the mid nozzle.The lens is advanced for the implantation from the mid nozzle area without stopping at the pause location to inspect the haptic position.Both haptics appears to be folded over the optic.As the lens is implanted and the lens begins to unfold, the leading haptic is observed to be broken.The lens is explanted, and a new lens is successfully implanted.Based on the review of the video, a broken leading haptic was observed.Lens preparation for the advancement was not provided.Without the evaluation of lens placement, a definitive determination of the reported complaint cannot be made.A final root cause cannot be determined based on available information.Close adherence to the ifu (instructions for use) provides the best opportunity for optimal delivery.Based on the results from the product history record, the products met release criteria.There have been no other complaints reported in the lot number.Correction information was provided in h.10.The complainant indicates the use of non-company or company as a viscoelastic.Non-company ovd is not qualified for use with company model.It is unknown which viscoelastic was used in this case.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL
• 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: 15495544
• MDR Text Key: 302087659
• Report Number: 9612169-2022-00497
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652251358
• UDI-Public: 00380652251358
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Lot Number: 25159311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 11/24/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEALON; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; VISCOAT
• Patient Age: 68 YR
• Patient Sex: Female