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

Lot Number 084655

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Deposits (1809)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

Based on the initial report (documentation analysis, complaint history and investigation of the returned lens) and the assessment by lenstec's medical monitor, lenstec concludes that there is no evidence to suggest that any aspect of the lens was responsible for this incident.Microscopic examination of the lens indicated that the bubbles seen were deemed superficial, stained for calcium and did not extend through the matrix of the lens.According to neuhann et al, non-lens factors are the likely cause of these bubbles seen.However, lenstec is unable to determine a definitive conclusion as to the cause.Additionally, lenstec can confirm that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Furthermore, there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.

Event Description

Lenstec received an email stating "lens needed to be explanted on the 21/5 due to glistening.".

• Brand Name: SOFTEC I
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 9008597
• MDR Text Key: 161998958
• Report Number: 9613160-2019-00023
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029766
• UDI-Public: 00844369029766
• Combination Product (y/n): N
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2013
• Device Lot Number: 084655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1