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

Model Number MA60AC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Inflammation (1932); Intraocular Pressure Increased (1937); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A sample product was not returned for analysis.Complaint history and product history record could not be reviewed because the article did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

In a literature article entitled, "transscleral sutureless intraocular lens versus retro pupillary iris-claw lens fixation for pediatric aphakia without capsular support: a randomized study," comparisons were made between sutureless transscleral intraocular lens (iol) fixation to retropupillary iris-claw lens implantation in cases of paediatric aphakia without capsular support.Both techniques yielded comparable visual outcomes.The manufacturer's iol was used for the transscleral fixated intraocular lens (iol) and a competitor's lens was the iris-claw lens.The manufacturer's lens was implanted into 15 eyes of 11 patients; 7 female and 4 male.During surgery, one eye had a broken iol haptic during exteriorization which required another iol to be implanted instead.Postoperative complications included: 2 eyes had iol decentration, 1 eye had inflammatory membrane causing a decrease in bcva by 0.15, 1 eye had a yag laser capsulotomy, 1 eye developed postoperative hypotony (iop < 6 mmhg) due to subconjunctival leakage at the sclerotomy site around the haptic, which resolved spontaneously after 2 weeks.2 eyes developed ocular hypertension, 10 months and 1 year postoperatively, and were managed medically, 3 eyes had subconjunctival exposure of the iol haptic, without conjunctival erosion and 1 eye developed optic capture 6 months postoperatively, which resolved after pupillary dilation by mydriatic drops.It was also reported that in the sutureless transscleral iol fixation group endothelial cell counts were decreased on the average by 14% at a six month postoperative measurement.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: 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 ; 8175514979
• MDR Report Key: 10033228
• MDR Text Key: 190185227
• Report Number: 1119421-2020-00752
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention