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

Lot Number 134162

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  Injury  

Event Description

On the 24th october 2014, lenstec received via email notification that the device was being returned.The lens in question was returned via the returns authorization numbers (ra#s)1239/62179, and was received on the 28th october 2014 with the notification "lead haptic amputated, sitting on optic upon delivery.Lc1645s used.Implant/explant date (b)(6) 2014, same model lens used successfully".Further information provided stated that the lens came out of the injector into the anterior chamber with the lead haptic severed and sitting on top of the optic.The optic was then cut to be removed from the eye.The incision was enlarged to remove the iol and there was no patient injury.

• 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: 10392282
• MDR Text Key: 202806941
• Report Number: 9613160-2020-00027
• 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: 05/13/2020

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: 10/15/2018
• Device Lot Number: 134162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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