MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Additional information has been requested and received.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the leading haptic of the iol opened normally but appeared to slice the lens capsule resulting in an anterior chamber lens needing to be implanted.Additional information was provided by the nurse, who reported that the according to the surgeon, the haptic sliced the lens capsule.He was not able to implant due to the slice in the capsule and removed immediately and stopped vitreous loss by using viscoelastic to tamponade the opening in the capsule.The procedure was completed with an anterior lens.No vitrectomy or other procedures were required.The patient has no residual symptoms.

Manufacturer Narrative

Evaluation summary: the lens and the associated cartridge were returned separately.The lens was torn/cut into two portions typical of an insertion and removal.One half of the lens was returned in the lens case.Viscoelastic was observed on the lens.The haptic on this portion was bent in the distal area.The other half of the lens was returned in a medicine bottle labeled as "half with leading haptic".Viscoelastic is dried on the lens portion that was returned in the medicine bottle.There were no sharp edges or damage observed to the haptic of this portion (identified as the leading haptic).The associated cartridge was returned with only a small amount of viscoelastic observed inside the cartridge.No damage was observed to the cartridge.The cartridge shows evidence of being placed into a handpiece.Product history records were reviewed and the documentation indicated the product met release criteria.The product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The customer indicated the use of a qualified handpiece.The viscoelastic is unknown.The product investigation could not identify a root cause for the complaint of 'leading haptic slice the lens capsule".There was no sharp edges or damage to the segregated haptic identified by the customer as the leading haptic.Additionally, only a small amount of viscoelastic was observed inside the cartridge.The directions for use instructs to fill the cartridge with viscoelastic before loading the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with viscoelastic, which may result in damage or delivery issues.(b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7450730
• MDR Text Key: 106167993
• Report Number: 1119421-2018-00445
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 12494878
• Other Device ID Number: 00380655093221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH D CARTRIDGE; MONARCH III HANDPIECE
• Patient Outcome(s): Other