MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT4

Device Problem Scratched Material (3020)

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

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.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 physician reported that, during intraocular lens (iol) implant procedure, scratch was observed on the surface of the iol optic.Iol was removed and new iol was implanted during the same procedure.Additional information was requested.

Manufacturer Narrative

Additional information was provided in h.3,h.6 and h.10.The lens was returned for evaluation.A large amount of blood and ovd (ophthalmic viscosurgical device) were observed dried on the lens.A strip of material was observed dried in the blood and solution on the posterior surface of the lens.The lens was cleaned with klrp.The material was isolated and sent to the particle lab for testing.The optic was cut from the edge to the center.A smaller cut was located just under the first cut.No scratches were observed.A short video was provided.The lens and cartridge preparation were not shown.The lens advancement and delivery were not shown.The video shows an implanted toric single-piece lens.A linear material or mark was observed on the posterior surface of the lens.The mark was at the 9¿oclock toward the 1 o¿clock position.An unsuccessful attempt was made to suction the area.The material removed from the lens was isolated and sent to the lab for testing.Microscopic examination showed a clear material approximately 2mm in length.The clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the clear material¿s generated spectra to a library of spectra found the best match to be company cartridge base coat.A qualified company and handpiece were indicated.The viscoelastic used was not provided.It is unknown if a qualified product was used.The reported lens damage was not observed.A video was provided of the reported ¿mark¿.The mark was not observed on the returned iol(intraocular lens) which had been cut across the center of the optic.A clear linear material was observed on the edge of the lens similar to what was observed on the provided video.The material removed from the lens was isolated and sent to the lab for testing.Microscopic examination showed a clear material approximately 2mm in length.The clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the clear material¿s generated spectra to a library of spectra found the best match to be company cartridge base coat.Based on these findings the reported scratch may have been coating material from company cartridge.The company cartridge was not retuned to evaluate for damage (pr(b)(4)).The ifu(instructions for use) instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15186012
• MDR Text Key: 300654969
• Report Number: 1119421-2022-01732
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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: SN6AT4
• Device Catalogue Number: SN6AT4A235
• Device Lot Number: 15123331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR