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

Model Number SOFTECI+21.0

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.The visual examination carried out revealed that the lens was intact, and no defects were present.The cartridge was not returned but is compatible with the lens.Lenstec recommends the user follows the instructions for use for the correct procedure for implanting the lens.

Event Description

Lenstec received an email stating that 'surgical tech had problems getting lens to properly load.After several attempts was able to load.Md didn't feel comfortable on lens insertion and then removed.Removed lens, reinserted new lens without difficulty.Enlarged incision-no patient injury'.

• 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: 10303436
• MDR Text Key: 199891185
• Report Number: 9613160-2020-00058
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECI+21.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 195061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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