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

Lot Number 132036

Device Problem Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 04/20/2015

Event Type  Injury  

Event Description

On the 2nd july 2015, lenstec ((b)(4)) inc.Received via email, a notification that the lens was being returned via the returns authorization numbers 1307/73958.The lens in question carried the notation "while inserting lens, a piece of lens was broken (but the lens was in patient's eye already), broken lens removed, patient contact, caused wide incision, suture needed".On the 6th july 2015, lenstec requested the client to provide the instruments used and the lot number of the cartridge.On the 13th july 2015, lenstec requested via email, a response to the information previously requested.On the 20th july 2015, lenstec made a third attempt to obtain the above requested information.Attempts to obtain the requested information proved futile to date.

Event Description

On the 2nd july 2015, lenstec (barbados) inc.Received via email, a notification that the lens was being returned via the returns authorization numbers 1307/73958.The lens in question carried the notation "while inserting lens, a piece of lens was broken (but the lens was in patient's eye already), broken lens removed, patient contact, caused wide incision, suture needed".On the 6th july 2015, lenstec requested the client to provide the instruments used and the lot number of the cartridge.On the 13th july 2015, lenstec requested via email, a response to the information previously requested.On the 20th july 2015, lenstec made a third attempt to obtain the above requested information.Attempts to obtain the requested information proved futile to date.

• 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: 10393009
• MDR Text Key: 202448175
• Report Number: 9613160-2020-00040
• 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: 07/20/2018
• Device Lot Number: 132036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1