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

Lot Number 121605

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

Patient Problem No Information (3190)

Event Date 12/04/2013

Event Type  Injury  

Manufacturer Narrative

Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Furthermore, the actual device inspection yielded correct lens dimensions and therefore, lenstec is unable to determine why the lens was decentered.

Event Description

Lenstec received an email stating that "customer indicated that lens was implanted in (b)(6) 2013 and then removed (b)(6) 2013 as the lens became slightly displaced.Surgeon implanted sulcus lens in patient.No injury reported.Surgery successful.".

• 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: 10062198
• MDR Text Key: 191537528
• Report Number: 9613160-2020-00042
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2017
• Device Lot Number: 121605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2015
• 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