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

Lot Number 124939

Device Problem Insufficient Information (3190)

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

Event Date 05/28/2014

Event Type  Injury  

Event Description

On the 4th june 2014, lenstec ((b)(4)) inc received via e-mail, a notification that lenses were being returned via the returns authorization number 1184.The lens in question carried the notation 'torn during procedure, the lens was implanted and removed".The lens was thrown away by mistake by a new employee in the operating room.The lenstec injector was used (the specific model/type was unknown); this was not returned for investigation.No further information regarding the cause of the torn lens, if there was any patient injury or if another lens was successfully implanted was provided.

Event Description

On the 4th june 2014, lenstec (barbados) inc received via e-mail, a notification that lenses were being returned via the returns authorization number (b)(4).The lens in question carried the notation 'torn during procedure, the lens was implanted and removed".The lens was thrown away by mistake by a new employee in the operating room.The lenstec injector was used (the specific model/type was unknown); this was not returned for investigation.No further information regarding the cause of the torn lens, if there was any patient injury or if another lens was successfully implanted was provided.

Manufacturer Narrative

(b)(4).

• Brand Name: SOFTEC HDO
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church,, ; BB
• MDR Report Key: 10392005
• MDR Text Key: 202805192
• Report Number: 9613160-2020-00015
• 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: 02/19/2018
• Device Lot Number: 124939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1