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

Lot Number 102463

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2015

Event Type  Injury  

Event Description

On the (b)(6) 2015, lenstec received an email notification stating "back haptic broke.Patient contact, implant/explant date (b)(6) 2015.No patient injury, same model lens used successfully".The lc1645s cartridge and the i-9011s injector were the instruments used.

Manufacturer Narrative

Attachment: (b)(4).

Event Description

On the (b)(6) 2015, lenstec received an email notification stating "back haptic broke.Patient contact, implant/explant date (b)(6) 15.No patient injury, same model lens used successfully".The lc1645s cartridge and the i-9011s injector were the instruments used.

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10392291
• MDR Text Key: 202533897
• Report Number: 9613160-2020-00031
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• 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: 07/31/2015
• Device Lot Number: 102463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1