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

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Corneal Edema (1791); Corneal Stromal Edema (1824)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, it was noted that, the optic was fractured when injecting and felt very stiff when moving in to the cartridge.Additional information has been received and stated that, the patient had edema, corneal striae.As per the reporter medical or surgical intervention is not required for the event.The procedure was completed with another lens of the same power and model was implanted during initial procedure.
Additional 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).
Additional Manufacturer Narrative
The lens in the lens case, the associated company cartridge, and an opened lens peel pouch were returned inside the opened carton.The lens was positioned incorrectly (posterior surface up) inside the lens case.Viscoelastic and possible blood was observed on the lens.One haptic was torn (still attached) in the distal area.The posterior optic surface has travelling scrape marks.The left side of the optic edge was torn, split, and cracked.A separate optic area was also cracked.The anterior optic surface has an area that was cracked directly above the damage located on the posterior surface.Viscoelastic was observed dried in the associated company cartridge.The cartridge tip has stress lines on all sides.Both wings of the cartridge were fully compressed, which indicated that the cartridge had been fully seated into the handpiece prior to delivery attempt.Photos were available of the lens and the cartridge.The images match the returned product condition.Information was provided that a qualified handpiece and viscoelastic were used with this qualified lens/cartridge combination.The root cause cannot be determined for the reported complaint.The reported optic fracture was observed.The cartridge tip has stress lines.Stress is a common occurrence and does not denote a cartridge deficiency.However, it can be more pronounced if there is an inadequate amount of viscoelastic between the lens and the cartridge lumen or if the lens is not positioned correctly.In addition, if the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.Also, the posterior of the optic had travelling scrape marks.This type of damage may be created by a plunger under riding the optic during lens delivery attempt.It is unknown if the end user biased the lens correctly during lens delivery preparation.The ifu (instructions for use) instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Failure to follow this step may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: 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: 16352197
• Report Number: 1119421-2023-00277
• Device Sequence Number: 12329717
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: 00380655093160
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: SN60WF
• Device Catalogue Number: SN60WF.185
• Device Lot Number: 15454381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION; DISCOVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Patient Age: 80 YR
• Patient Sex: Male