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

Lot Number 142515

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

Patient Problem Vitrectomy (2643)

Event Date 06/02/2015

Event Type  Injury  

Event Description

On the 4th june 2015, lenstec ((b)(4)) inc.Received via email, a notification stating that although the above lens was destroyed at the facility, it was listed on the returns authorization number (ra#) 72649.The report stated "lens had patient contact, vitrectomy performed, tear in capsule.Implant/explant date (b)(6) 2015, no pt injury, different model lens placed in sulcus".Further information provided stated that the lens was not the cause of the capsular tear.

Manufacturer Narrative

Attachment: [c1166.Pdf, mdr narrative for capa 318.1.Pdf].

Event Description

On the (b)(6) 2015, lenstec (barbados) inc.Received via email, a notification stating that although the above lens was destroyed at the facility, it was listed on the returns authorization number (ra#) 72649.The report stated "lens had patient contact, vitrectomy performed, tear in capsule.Implant/explant date (b)(6) 2015, no pt injury, different model lens placed in sulcus".Further information provided stated that the lens was not the cause of the capsular tear.

• Brand Name: SOFTEC I
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10392945
• MDR Text Key: 202444065
• Report Number: 9613160-2020-00037
• 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: 07/27/2019
• Device Lot Number: 142515
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1