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

Model Number MA60AC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Visual Disturbances (2140)

Event Date 02/05/2007

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.The manufacturer internal reference number is: (b)(4).

Event Description

A literature article reported that a female was diagnosed with a large temporal retinoschisis extending almost to the macular region, as well as with an incipient corticonuclear cataract in the left eye.To prevent potential macular involvement, cataract extraction was performed to increase visibility before a subsequent retinal reattachment procedure.Phacoemulsification with an intraocular lens (iol) implantation was performed and according to the operating report, the procedure was uneventful.Four (4) days postoperatively, a glistening formation within the iol optic was observed under a slit lamp examination.The pattern appeared different from the one the examining ophthalmologist had seen before.The intensity of the glistening formation was significant, and some of the vacuoles were very large.On (b)(6) 2007, a retinal reattachment procedure, including circular scleral buckling, pars plana vitrectomy, liquid perfluorocarbon injection, endolaser, and gas tamponade, was performed elsewhere.Partial pupil optic capture was observed on the first postoperative day.On (b)(6) 2007, the retina was well attached.However, visualization of the retinal fundus was impaired, which was attributed to the presence of the intense glistenings within the iol optic.The aspect of the glistenings was overall unchanged from that seen 4 days after the cataract procedure.Removal/exchange of the iol was performed on (b)(6) 2007.According to the operating report, the iol was easily removed and replaced with a lens from another company, fixated in the capsular bag.Additional information has been requested.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8469642
• MDR Text Key: 140496340
• Report Number: 1119421-2019-00391
• 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: Physician
• Type of Report: Initial
• Report Date: 04/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.210
• Device Lot Number: 123592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2006
• 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