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

Lot Number 140662

Device Problem Device Handling Problem (3265)

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

Event Date 09/10/2014

Event Type  Injury  

Event Description

On the 26th september 2014, lenstec ((b)(4)) inc.Received via email, a notification that lenses were returned via the returns authorization number 1229.The lens in question carried the notation "lens was loaded into the injector, while doctor was inserting lens into the eye, haptic broke and was left in the cartridge.Doctor cut lens in half and removed lens, new lens was inserted, same model.Implant/explant date (b)(6) 2014.The lc1620 cartridge and the push injector were the instruments used.

Event Description

On the (b)(6) 2014, lenstec (barbados) inc.Received via email, a notification that lenses were returned via the returns authorization number (b)(4).The lens in question carried the notation "lens was loaded into the injector, while doctor was inserting lens into the eye, haptic broke and was left in the cartridge.Doctor cut lens in half and removed lens, new lens was inserted, same model.Implant/explant date (b)(6) 2014.The lc1620 cartridge and the push 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: 10392164
• MDR Text Key: 202807379
• Report Number: 9613160-2020-00024
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Lot Number: 140662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 09/26/2014
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1