MAUDE Adverse Event Report: LENSTEC BARBADOS, INC. SOFTEC HD PLI; INTRAOCULAR LENS

Lot Number 133097

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2014

Event Type  Injury  

Event Description

On the 23rd june 2014, lenstec ((b)(4)) inc.Received via email, a customer complaint about black particles in the pli (preloaded injector).The lens was implanted on the (b)(6) 2014.No further information was provided despite several requests being made for the hospital to complete the complaint form.

Event Description

On the 23rd june 2014, lenstec (b'dos) inc.Received via email, a customer complaint about black particles in the pli (preloaded injector).The lens was implanted on the (b)(6) 2014.No further information was provided despite several requests being made for the hospital to complete the complaint form.

• Brand Name: SOFTEC HD PLI
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10392074
• MDR Text Key: 202443766
• Report Number: 9613160-2020-00019
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2016
• Device Lot Number: 133097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1