MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/04/2024
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 physician reported that during an intraocular lens (iol) implant procedure, once implanted in the eye, a break was identified in the central area of the optic of the lens.The iol was explanted during initial procedure.Additional information has been requested, received and stated the lens that had the rupture was removed and another same model company lens was implanted.The patient had postoperative inflammation.
Additional Manufacturer Narrative
The product was returned for analysis and the reported damage was observed.Intraocular lens (iol) returned positioned incorrectly in the iol case.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is adhered to the optic surface with solution, the other haptic is returned.The optic is torn/split-cut and scratched/marked-rejectable.The reporter states the use of "hanita" and viscoshield" as viscoelastic, which are not qualified to be used with the associated iol model.Photo review: photo provided shows an implanted iol.There appears to be a large crack/mark on the optic area of the lens.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.The product was subject to handling and the reported damage was highlighted post implantation.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The sterilisation reports were reviewed and there were no issues with the sterilisation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19260302
• Report Number: 9612169-2024-00408
• Device Sequence Number: 20456161
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: 00380655093160
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/19/2024

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: SN60WF
• Device Catalogue Number: SN60WF.185
• Device Lot Number: 25709539
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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: ACRYSOF IQ NATURAL SINGLEPIECE IOL; CENTURION VISION SYSTEM,ACTIVE SENTRY HANDPIECE; HANITA; MONARCH III IOL CARTRIDGE D; VISCOSHIELD
• Patient Sex: Male