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

Model Number	SA60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Eye Injury (1845); Inflammation (1932)
Date of Event	07/09/2024
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 health care professional reported that during an intraocular lens (iol) implant procedure, nurse load iol into cartridge and injector but did not observed lens before.Then pass to surgeon for implantation.This was common practice of the site and no prior event like this.Surgeon noticed vacuole-like and scratch mark on the lens after loading into patient¿s eyes and had to cut the lens to extract it out in the same operation.But had to widen the cut mark to remove the pieces of lens out.A new iol replaced in the same operation but took longer time to finish and as a result wound was widen than usual had to stitch the wound close.Patient had inflammation and antibiotics was given after the surgery and does not require additional hospital stay.There are three medical device reports associated with this report.This is 3 of 3.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.Three sets of photos were provided of the three single-piece lenses.The customer did not provide identification for the photos.It is unknown which photo goes to each file.The scratch observed for the first pictured lens was on the anterior surface.This damage was similar in appearance to damage caused by an instrument used to grasp the lens.If the lens is loaded properly, the anterior surface does not contact the inner lumen of the cartridge.The second and third pictured lenses had scrape marks on the posterior surface near the edge.The lenses had little to no viscoelastic visible in the photos.The scrape mark damage observed near the edge can occur due to rapid advancement and/or with inadequate viscoelastic in the cartridge.Qualified associated products were indicated.Based on review of the provided photos the lenses were damaged.The root cause for the observed damage could not be definitively determined from the photos.The first lens was scratched on the anterior surface.This damage was similar in appearance to damage caused by an instrument used to grasp the lens.If the lens is loaded properly, the anterior surface does not contact the inner lumen of the cartridge during delivery.The second and third pictured lenses had scrape marks on the posterior surface near the edge.The lenses had little to no viscoelastic visible in the photos.The scrape mark damage observed near the edge can occur due to rapid advancement and/or with inadequate viscoelastic in the cartridge.The ifu (instructions for use) instructs to completely fill the cartridge with ovd (ophthalmic viscoelastic device) 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 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 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 manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 19919052
• Report Number: 1119421-2024-01517
• Device Sequence Number: 7244715
• Product Code: HQL
• UDI-Device Identifier: 00380652332675
• UDI-Public: (01)00380652332675(17)281014(11)231017(10)15735171
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.205
• Device Lot Number: 15735171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 10/17/2023
• 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 CARTRIDGE C.; MONARCH INJECTOR.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown