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

Model Number MA60AC

Device Problem Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Two company lenses were returned adhered to each other and to the outside of the lens case.It cannot be determined which lens is for which file as the lenses are the same lot, diopter.The evaluations will be placed in both qs records.The lenses were numbers 1-2 for evaluation purposes.The lenses were cleaned with klrp to separate.Only one of the lenses was scratched.This lens had one haptic pulled from the optic.The second haptic was bent gusset area.A narrow scratch was observed on the posterior optic surface.The optic was also broken on the edge with material removed at the insertion area of the removed haptic.Multiple scratches were observed in this area.The scratches travel from the edge inward.These scratches are not in the travel/fold path.These appear to have been cause by an instrument used to grasp the lens.Two small parallel cracks were also observed in the center of the optic (anterior and posterior).This damage also appears to have been caused by an instrument used to grasp the lens.The second used company lens also had one haptic pulled from the optic.The optic was cracked in the haptic insertion area.The second haptic was bent-gusset area.The optic was torn in this haptic insertion area.No scratches were observed.The used company cartridges were not returned.Seven unopened company cartridges were returned for the reported lot.One unopened sample was pulled randomly for testing.The unopened company cartridge was microscopically examined with no damage or abnormalities observed.No particulate was observed inside the cartridge.The cartridge was functionally tested per the dfu (directions for use) using a qualified handpiece, company, 22.5 diopter lens and viscoelastic.The cartridge was filled with viscoelastic per the ifu.The lens was loaded and biased down.The lens was advanced making sure the plunger was in the correct position in contact with the trailing optic edge.No lens or cartridge damage was observed after the lens delivery.The company cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.The associated cartridge was qualified.Two viscoelastics were indicated it is unknown which was used in the cartridge.The handpiece model was not provided.It is unknown if a qualified handpiece was used.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause could not be determined for the reported scratches.Only one of the returned company lenses was scratched.This lens had multiple areas of damage, which were not it the lens fold/travel path.The damage appeared to have been caused by instruments used to grasp the lens.Both lenses had haptics pulled from the optic and bent haptics.All four haptic insertion areas were damaged.The used company cartridges were not returned.One of the returned unopened company cartridges was evaluated.No damage or abnormalities were observed.Functional and dye stain testing was conducted with the unopened sample with acceptable results.No lens or cartridge damage was observed after the functional test.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified handpiece was used.The ifu(instructions for use) instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu 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.The ifu instructs: use holding forceps to grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until it is centered with or slightly past the outline etched into the top of the cartridge.The trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

Event Description

A health care professional reported that during an intraocular lens (iol) implant procedure, scratched lenses, noted plastic fragments inside the cartridge after lens was inserted.Patient was left aphakic.Additional information was requested, but no further information is available.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was requested, and received stating the patient was not left aphakic.Lens was replaced with another lens with same model and diopter lens on same day.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 18895456
• MDR Text Key: 337563568
• Report Number: 1119421-2024-00471
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652552516
• UDI-Public: 00380652552516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.195
• Device Lot Number: 15257590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC SYSTEM; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Patient Age: 58 YR
• Patient Sex: Male