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

Model Number SOFTECI+23.0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  Injury  

Event Description

Lenstec received an email stating " once lens was implanted, haptics were amputated, removed, implanted same diopter hd lens.No patient injury but suture enlarged.".

Manufacturer Narrative

Based on the review of the batch documentation conducted, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.Additionally, we have not received any other complaints from these batches.Furthermore, after device evaluation it was determined that the damage to the haptics suggests that the incorrect technique was used to load and eject the lens, indicating the manufacturers instructions for use were not followed.

• 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 33716 ; 7275712272
• MDR Report Key: 15944660
• MDR Text Key: 305140896
• Report Number: 9613160-2022-00019
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029568
• UDI-Public: 00844369029568
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECI+23.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 221744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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