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

Lot Number SB01446

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

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  Injury  

Event Description

On the (b)(6) 2015, lenstec received an email notification stating that the device was being returned.The lens in question was returned via the returns authorization numbers (ra#)1329/77515 and it was received at lenstec (barbados) inc.On the (b)(6) 2015 with the notification "deposits on lens.Patient contact".On (b)(6) 2015, lenstec received an update which stated "it was white debris similar to a smear which appeared to be visually significant.Debris was noted after implantation.Incision was mildly enlarged, lens was cut, wound was self-sealing.No sutures needed.Another softec was implanted.No injury to the patient.Information relating to the implant/explant date, patient history or the patient's current condition was not provided.

Event Description

On the 3rd september 2015, lenstec received an email notification stating that the device was being returned.The lens in question was returned via the returns authorization numbers (ra#)(b)(4) and it was received at lenstec (barbados) inc.On the 7th september 2015 with the notification "deposits on lens.Patient contact".On 9th september 2015, lenstec received an update which stated "it was white debris similar to a smear which appeared to be visually significant.Debris was noted after implantation.Incision was mildly enlarged, lens was cut, wound was self-sealing.No sutures needed.Another softec was implanted.No injury to the patient.Information relating to the implant/explant date, patient history or the patient's current condition was not provided.

• 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: 10393049
• MDR Text Key: 202524048
• Report Number: 9613160-2020-00041
• 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: 03/06/2016
• Device Lot Number: SB01446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability