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

Model Number	SOFTECHD+14.0
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.The device was destroyed at the facility thus batch audit was conducted and revealed no manufacturing issues.
Event or Problem Description
Lenstec received an email stating " lens implanted (b)(6) 2018 and expalnted on (b)(6) 2020.Right eye calcification of lens implant.Implanted ar40 14.0 with no adverse event for patient.Lens destroyed at the facility was reported".
Additional Manufacturer Narrative
Based on the investigation previously carried out (documentation analysis, complaint history) and with the current assessment from lenstec's medical monitor, lenstec concludes that there is no evidence to suggest that the lens is at fault.The medical monitor stated that as the iol was exposed to an unexpected environment, it is presumed that this environment can alter material transparency.Additionally, lenstec can confirm that the lens, its design, and the manufacturing process are not at fault due to extensive testing that we have performed on this model.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration, or opacification for our hema lenses.
Event or Problem Description
Lenstec received an email stating " lens implanted (b)(6) 2018 and explanted on (b)(6) 2020.Right eye calcification of lens implant.Implanted ar40 14.0 with no adverse event for patient.Lens destroyed at the facility was reported".

• 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: 11197271
• Report Number: 9613160-2021-00001
• Device Sequence Number: 16313021
• Product Code: HQL
• UDI-Device Identifier: 00844369027137
• UDI-Public: 00844369027137
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 02/25/2023
• Device Model Number: SOFTECHD+14.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 174973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1