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

Model Number	SOFTECHD+13.5
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Deposits (1809)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The microscopic examination of the lens indicated that the opacity was 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.Lenstec's medical monitor indicates 'a class effect when prolonged air/gas bubbles are present in the setting of breakdown of the blood-aqueous barrier'.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.Lenstec also confirms that all procedures in the manufacturing and packaging of the lens were conducted correctly.(b)(4).
Event or Problem Description
Lenstec received an email stating "lens became opacified, it was implanted on the (b)(6) 2014.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10076045
• Report Number: 9613160-2020-00045
• Device Sequence Number: 11471935
• Product Code: HQL
• UDI-Device Identifier: 00844369027120
• UDI-Public: 00844369027120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2018
• Device Model Number: SOFTECHD+13.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 133011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1