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

Lot Number 141055

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, lenstec received via email notification that the device being returned.The lens in question was returned via the authorization numbers (ra#s) (b)(4), and received on the 21st october 2014 with the notification "broken haptic and stuck in delivery system.Implant/explant date (b)(6) 2014.Same model lens used successfully".The lc16 cartridge was used.Further clarification provided stated that "the cartridge is what was meant by the lens was stuck in the 'delivery system'.

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, bb, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, bb, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 10593215
• MDR Text Key: 208782956
• Report Number: 9613160-2020-00062
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2019
• Device Lot Number: 141055
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• 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