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

Lot Number 132411

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

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

Event Date 04/30/2014

Event Type  Injury  

Event Description

The lenses in question carried the notation "cartridge defective".For serial number (b)(4), the reason for return was cartridge splitting - damages the lens.The lenstec cartridge with the reusable injector (the specific model was unknown) was used.The lens was not fully implanted (half way in).It was then removed.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.

Event Description

The lenses in question carried the notation "cartridge defective".For serial number (b)(6), the reason for return was cartridge splitting - damages the lens.The lenstec cartridge with the reusable injector (the specific model was unknown) was used.The lens was not fully implanted (half way in).It was then removed.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.

• Brand Name: SOFTEC HDO
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10392023
• MDR Text Key: 202701485
• Report Number: 9613160-2020-00016
• 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: user facility
• 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: 06/30/2018
• Device Lot Number: 132411
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1