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

Lot Number 133827

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/16/2014

Event Type  Injury  

Event Description

On the (b)(6) 2014, lenstec (barbados) inc received via email, a notification that lenses were being returned via the returns authorization number 1184.The lenses in question carried the notation "cartridge defective".No further information regarding the lot number for the cartridge, if there was any patient injury, or if another lens was successfully implanted was provided.The lenses were received at lenstec (barbados) inc on the (b)(6) 2014.

• Brand Name: SOFTEC HDO
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n; st. petersburg, fl ; 5712272
• MDR Report Key: 10392067
• MDR Text Key: 202701392
• Report Number: 9613160-2020-00017
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2020

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: 09/15/2018
• Device Lot Number: 133827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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