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

Model Number	ACU0T0
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported with a description of haptics seemed to be amalgamated with the intraocular lens (iol) and the lens itself was almost mangled.Additional information has been requested.
Additional Manufacturer Narrative
Only the lens was returned posterior surface up in a small blue slide top company container loose inside the product carton.Solution was dried on the lens.The optic anterior surface was scraped near one haptic/optic junction travelling toward the edge.A long scrape mark was observed near the optic center and a lighter scratch mark was observed between the optic center and the optic edge.A cracked area of damage was observed near the optic edge.The posterior of the optic has a long light scratch near the optic center.A deep gouge mark was observed near the optic edge.Two scrape marks were observed between the optic center and the optic edge.A cracked area of damage was observed near one haptic/optic junction.Both haptics have areas of thinner anterior surface areas which would not meet release criteria.Both haptics are fully intact to the optic.Neither haptic was stuck to the optic (amalgamated) upon return.A photo was provided which displayed the lens posterior surface up.The anterior surface of the haptics would not be visible in this photo.A linear line of optic damage was observed in the photo.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported complaint of "haptics seemed to be amalgamated with the lens and the lens itself was almost mangled".Neither haptic was adhered to the optic upon return.The position of the haptics during lens delivery inside the device cannot be determined because only the lens was returned.The optic was damaged.The evidence of scrape marks on the anterior and posterior surfaces of the optic may suggest that more than one attempt to deliver the lens occurred.A previous plunger override, plunger retraction, and a plunger underride may have occurred during this event based on the observed optic damage.Per the instructions for use (ifu): gently advance the plunger in one smooth, continuous motion to deliver the intraocular lens (iol).Maintain adequate pressure to ensure the nozzle tip remains in the incision.Do not advance the plunger too fast or lens damage may occur.It is recommended that delivery of the lens from the fill-to line through the nozzle should take at least 5 seconds.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, a 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.Plunger override or underride may occur: ¿ due to rapid advancement faster than the ifu recommend 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 inadequate viscoelastic is placed in the device, this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.¿ if the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.¿ if the operating room temperature is too high (> 23°c / 73° f) 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 of "lens itself was almost mangled".Based on observations of the returned sample and separate from the complaint, a manufacturing related cosmetic imperfection was observed.The anterior surface of both haptics displayed thinner anterior surface areas.This haptic characteristic occurred during the manufacturing milling operation.The decreased haptic anterior surface areas would not meet manufacturing release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 19132545
• Report Number: 1119421-2024-00744
• Device Sequence Number: 6854039
• Product Code: KYB
• UDI-Device Identifier: 00380652395212
• UDI-Public: 00380652395212
• 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): 07/10/2024

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 Expiration Date: 06/13/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15663575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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
• Patient Sex: Unknown