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

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, while inserting the lens and deploying the haptics, they noticed that one haptic was loose.So, they proceeded to remove the lens and replace it with another iol of the same diopter.Lens with amputated haptic inside the capsular bag.The amputated haptic was the proximal one, that was the one that pushes the injector.During the implantation there was no resistance from the injection mechanism.Additional information received stating that the lens was removed and replaced during the same procedure.It was cut inside the anterior chamber and removed in pieces.A new lens with the same diopter strength was injected as the one that was removed.The incision was enlarged, and a suture was left.There was corneal edema, which was in the process of deflation.Anatomically, the lens was centered in the capsular bag, the pupil was round, and the chamber was formed.The patient¿s outcome was unchanged.
Additional Manufacturer Narrative
The product was not returned for analysis.Provided photo shows an intraocular lens (iol) carton and a closed lens case (lens case with sn (b)(6)).The reported event cannot be confirmed from the returned photo.The reporter states the use of "non-company ovd", this is not qualified for use with the associated iol model.The reported complaint could not be observed on the returned photo and no sample was returned for analysis; however, 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 viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was returned for analysis and the reported complaint was observed.Intraocular lens (iol) returned in lens case in four segments, adhered to each other with solution.Both haptics are broken or torn and returned.The optic is torn or split-cut dividing the iol in two and scratched or marked-rejectable.Photo review: provided photo shows an iol carton and a closed lens case.The reported event cannot be confirmed from the returned photo.Additional photos provided shows an opened lens case, a mangled iol is observed in the lens case base well.Additional information: the reporter states the use of non-company ophthalmic viscosurgical devices (ovd), this is not qualified for use with the associated iol model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.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 viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation 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: 20692583
• Report Number: 9612169-2024-01181
• Device Sequence Number: 18002329
• Product Code: HQL
• UDI-Device Identifier: 00380655093245
• UDI-Public: (01)00380655093245(17)290121(11)240124(10)25784866
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: SN60WF
• Device Catalogue Number: SN60WF.225
• Device Lot Number: 25784866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: BIOVISC OVD; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female