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

Lot Number 133817

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

Patient Problem Vitrectomy (2643)

Event Date 05/25/2015

Event Type  Injury  

Event Description

On the (b)(6) 2015, lenstec (barbados) inc.Received an email notification stating that there was a capsule rupture caused by a softec hd lens.According to the doctor,(dr.(b)(6) the lens came out of the inserted in a vertical position and as it unfolded, instead of flipping into postion, it caught on the capsule and as it continued to open it stretched and ultimately tore the capsule.Additional information provided by dr.(b)(6) stated: "the surgery was going completely normal except that the lens came out of the tip vertical and the haptic unfurling put pressure on the anterior capsule which then rented through to the backs; an anterior vitrectomy was performed to clean up; the lens is sitting nicely and the patient should be fine now; viscoelastic was used in the tip as this gives better motion and damping; lens remains in position.Capsule did not appear to be fragile at all and he felt it was the orientation that the haptic came out in which caused the rent in the capsule".

Event Description

On the (b)(6) 2015, lenstec (barbados) inc.Received an email notification stating that there was a capsule rupture caused by a softec hd lens.According to the doctor,(dr.(b)(6)), the lens came out of the inserted in a vertical position and as it unfolded, instead of flipping into postion, it caught on the capsule and as it continued to open it stretched and ultimately tore the capsule.Additional information provided by dr.Foo stated: "the surgery was going completely normal except that the lens came out of the tip vertical and the haptic unfurling put pressure on the anterior capsule which then rented through to the backs; an anterior vitrectomy was performed to clean up; the lens is sitting nicely and the patient should be fine now; viscoelastic was used in the tip as this gives better motion and damping; lens remains in position.Capsule did not appear to be fragile at all and he felt it was the orientation that the haptic came out in which caused the rent in the capsule".

• Brand Name: SOFTEC HD PLI
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS, INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10392971
• MDR Text Key: 202534431
• Report Number: 9613160-2020-00035
• 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: 09/18/2016
• Device Lot Number: 133817
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 05/27/2015
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1