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

Lot Number 134715

Device Problem Device Handling Problem (3265)

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

Event Date 09/23/2014

Event Type  Injury  

Event Description

On the 10th october 2014, lenstec received via email notification that the device was being returned.The lens in question was returned via the returns authorization numbers (ra#s) (b)(4), and was received on the 14th october 2014 with the notification "broken haptic, loading issues, implant/explant date (b)(6) 2014.Same model lens used successfully".The lc1645s cartridge was used.Further clarification provided states that " the loading issue was the trailing haptic was cut off when it came out in the eye.The incision was enlarged, the iol was removed using a mcpherson forcep, viscoelastic was injected and a new lens, same power was loaded using a different cartridge and implanted without difficulty".

• Brand Name: SOFTEC HD
• 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: 10392144
• MDR Text Key: 202523765
• Report Number: 9613160-2020-00025
• 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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2018
• Device Lot Number: 134715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2014
• 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