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

Model Number	SOFTECHD+17.0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Deposits (1809)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec cannot corroborate the device problem as the lens remains implanted.However, based on the documentation analysis and complaint history, the preliminary findings indicate that there is no evidence to suggest that any aspect of the lens was responsible for the incident.Lenstec is unable to determine a definitive conclusion as to the cause due because an investigation cannot be completed at this time since the lens is implanted.However, it is reported the patient suffered from diabetes and had an iris prolapse and a shallow anterior chamber during surgery.A supplemental report will be submitted once additional information is obtained.
Event or Problem Description
Lenstec received an email stating "the iol has brown deposits.Lens was inserted in 2012 on the public system.The patient's vision has dipped because of this and possibly will need an iol exchange".
Event or Problem Description
Lenstec received an email stating "the iol has brown deposits.Lens was inserted in 2012 on the public system.The patient's vision has dipped because of this and possibly will need an iol exchange.".
Additional Manufacturer Narrative
Based on the initial report (documentation analysis, complaint history and review by medical monitor) at this supplemental report with additional information, lenstec is unable to determine a specific cause for the unsubstantiated complaint of brown deposits.Additionally, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Lenstec is unable to perform a more through investigation of the complaint as the lens remains implanted.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.

• 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: 9577463
• Report Number: 9613160-2020-00003
• Device Sequence Number: 14213584
• Product Code: HQL
• UDI-Device Identifier: 00844369027199
• UDI-Public: 00844369027199
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 04/20/2013
• Device Model Number: SOFTECHD+17.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 081747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1