MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number MTA3U0

Device Problem Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Scarring (2061)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A nurse reported that following an intraocular lens (iol) implant procedure, the haptic was noted to be going through the patients peripheral iridotomy.While surgeon was repositioning the lens in a secondary procedure, it was noted that there was quite a bit of scarring around the haptic.While trying to reposition, the patient's eye started to bleed and the lens had to be removed.The decision was made to replace the iol with the identical lens originally implanted, but due to significant issues with visualization due to bleeding, the iol was removed and the patient was left aphakic.

Manufacturer Narrative

Product evaluation: the lens was returned.Viscoelastic and blood were observed dried on the lens.There is no damage observed to the haptics or to the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause cannot be determined by the evaluation of the sample.Information was provided that a facility representative reported the intraocular lens was inserted then removed due to poor view of lens placement.Needed to remove due to not being able to safely position lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8295146
• MDR Text Key: 134695172
• Report Number: 1119421-2019-00115
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P880087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• 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: 01/31/2018
• Device Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.195
• Device Lot Number: 12212237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR