MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A healthcare professional reported that during the intraocular lens (iol) implant procedure, the lens was injected and unfortunately once opened in the eye it was noticed that the lens had a large crack in the center.The lens removed and replaced and there was no complications.In follow-up visit the surgeon observed corneal edema due to prolonged surgery and only able to visually count fingers and treatment was given.Additional information has been received that patient had suture of wound.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The device and the lens were returned.The used device was evaluated.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.The nozzle tip has stress lines and a wide aneurysm that has stretched the posterior of the tip from the wound guard to tip exit.The lens was returned adhered posterior surface up on a set of small blank label stickers.Viscoelastic and blood was dried on the lens.One haptic was broken in the gusset area.The broken haptic was not returned.The lens was soaked in klrp to remove from the label set.After the dried viscoelastic, dried blood, adhesive and paper from the label set was removed, the lens was allowed to air dry prior to evaluation.A small area of the optic edge was split.This damage travelled further toward the optic center.The optic has two areas that were torn and split (possibly cut) from the optic edge.This damage extended into one center point of the optic.The damage was typical in appearance to damage from insertion and removal.The posterior of this damaged area has cracked optic material observed.Scratches were also observed on the posterior optic surface near the center.A separate area of the optic was cracked near the center.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The used device and the lens were returned separately.The reported lens damage was observed.The root cause for the reported lens damage may be related to a failure to follow the (instructions for use) ifu.A non-qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.The plunger was retracted upon return.The damage observed to the used device tip posterior would suggest that the lens and/or plunger were not in a proper position for advancement per the ifu.The ifu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be out of position can result in a broken haptic or other negative outcome.Based on the damage to the posterior tip, a previous plunger override may have occurred.Plunger override may occur: due to rapid advancement faster than the ifu recommended rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If the operating room temperature is too high (> 23 degree celsius / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.Information indicated that the lens was removed during initial surgery and replaced.The returned lens had additional evidence consistent with damage typically created to help facilitate the removal of a lens from the eye.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• 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: 20520672
• Report Number: 1119421-2024-02069
• Device Sequence Number: 20774672
• Product Code: HQL
• UDI-Device Identifier: 00380652395366
• UDI-Public: (01)00380652395366(17)261111(11)231113(10)15752769
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15752769
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALON PRO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown