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

Model Number	MA60MA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported haptic damage may be related to a failure to follow the instruction for use (ifu).A non-qualified lens/ company cartridge combination was indicated.The ifu instructs that an 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.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.There are no other complaints in this lot the manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, during an intraocular lens (iol) implantation procedure, it was observed that, the haptic came broken.A replacement of iol has been requested.Additional information was received by the consumer that, a new implant was performed during a secondary procedure without any problems.Patient was very satisfied with the surgical result.
Additional Manufacturer Narrative
Corrected information was provided in d.10 (previously: cartridge c and iii iol delivery system was reported).The lens was returned in the non-qualified (b) cartridge between the loading area and the nozzle entry area.Viscoelastic was observed in the cartridge.The leading haptic was broken in the distal area.The broken portion was located in the tip of the cartridge.The trailing haptic was back towards the loading area.The optic was misfolded sideways towards the left side of the cartridge and up instead of biased down per the instructions for use (ifu).The cartridge shows evidence it was placed into a handpiece.No tip damage observed.A non-qualified lens/cartridge combination was indicated.The lens model is only qualified for use in the (a) cartridge.The root cause for the reported haptic damage may be related to a failure to follow the ifu.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.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.In addition, the lens was misfolded to the left and pressed up against the roof of the cartridge, which would indicate the lens was not biased down.The ifu instructs 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.Failure to follow this step may cause the lens to advance incorrectly causing delivery issues and/or damage.There are no other complaints in this lot.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is:(b)(4).

• Brand Name: ACRYSOF MULTIPIECE 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: 12933283
• Report Number: 1119421-2021-02314
• Device Sequence Number: 4787861
• Product Code: HQL
• UDI-Device Identifier: 00380650699251
• UDI-Public: 00380650699251
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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 Expiration Date: 01/19/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.020
• Device Lot Number: 15127279
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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 II IOL CARTRIDGE B; MONARCH II IOL DELIVERY SYSTEM; MONARCH III IOL CARTRIDGE C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male