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

Model Number	SA60AT
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
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 surgeon reported during intraocular lens (iol) implant procedure, after implantation the surgeon noticed that the two haptics are in the posterior side.The procedure was completed on same day.Additional information has been requested.
Additional Manufacturer Narrative
Correction information was provided in d.4.Product udi has been updated.Additional information was provided in d.9., h.3., h.6.And h.11.Only a broken haptic was returned inside the lens case in the lens carton.Viscoelastic was observed on the haptic.The haptic was broken in the haptic/optic junction.A video was provided.The lens and cartridge preparation were not shown.The lens loading was not shown.The video started with single-piece lens already implanted into the eye.A broken haptic was observed under the trailing optic edge and was partially adhered to the trailing haptic.The haptic was removed with an instrument.This pulled the trailing haptic out of the incision.The trailing haptic was positioned back into the eye and the video ends.Two photos were provided of a broken clear haptic in a lens case, matching the returned product.Product history records were reviewed, and documentation indicated the product met release criteria.A nonqualified cartridge was indicated with a qualified handpiece and viscoelastic combination.The root cause cannot be determined for the reported complaint of "two haptics appeared in the posterior side".The video shows a broken haptic under the trailing optic edge and this haptic was partially adhered to the trailing haptic.The video showed the broken haptic being removed.Two photos were provided of a broken haptic placed in the lens case.A broken haptic was returned in the lens case with viscoelastic present.It cannot be determined from the video where the broken haptic originated.It should have been readily apparent when manually folding the trailing haptic during loading if it were on the lens when opened.It cannot be determined it the haptic was attached to the handpiece or another instrument used to load/advance the lens.The instructions for use (ifu) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ophthalmic viscosurgical device (ovd)-filled cartridge.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.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The returned broken haptic is similar in appearance to handling related damage.A non-qualified cartridge was indicated with this lens.The ifu instructs: company foldable intraocular lens (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a 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.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF 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: 20666247
• Report Number: 1119421-2024-02202
• Device Sequence Number: 7238781
• Product Code: HQL
• UDI-Device Identifier: 00380652555869
• UDI-Public: (01)00380652555869(17)280509(11)230512(10)15642831(21)15642831038
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.230
• Device Lot Number: 15642831
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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: MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown