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

Lot Number 131945

Device Problem Device Handling Problem (3265)

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

Event Date 11/06/2014

Event Type  malfunction  

Event Description

On the 21st november 2014, lenstec received via email notification that the device was being returned.The lens in question was returned via the authorization number (ra#) 1246/63561 on the 25th november 2014 wih the notification "when inserted into the eye, doctor realized there were lines in the lens.Patient contact, implant/explant date (b)(6) 2014, same model lens used successfully.Lc1645 used".Additional information was requested on the 25th november 2014 to obtain the lot number of the lc1645 cartridge used, if the incision was enlarged to remove the iol and if there was any patient injury.This information was not provided despite several attempts made.

• Brand Name: SOFTEC I
• 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: 10392301
• MDR Text Key: 202807769
• Report Number: 9613160-2020-00028
• 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

• 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: 09/04/2018
• Device Lot Number: 131945
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2013
• 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