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

Model Number	SOFTEC I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/22/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A distributor reported to lenstec an incident where an explant occurred for a possible "opacification".The distributor also stated that the patient was diagnosed with pco and that the explanted lens was not available for examination.Communication with the facility specified that they did not have any requested information.Lenstec is unable to comment on the nature of the opacification or make a definitive conclusion as to the cause of the opacification as the lens was not returned for inspection.Based on our assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Lenstec believes 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, lenstec can confirm that we have never had any confirmed lens-related cases of opacification for our hema lenses.
Event or Problem Description
Lenstec received email notification reporting that a +23.50 d softec 1 iol, which was implanted in 2004, got cloudy and required explant.The patient was diagnosed with posterior capsular opacification and the explanted lens is not avaialble for examination.

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS- SOFTEC I
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church BB170 92; BB BB17092
• MDR Report Key: 5571466
• Report Number: 9613160-2016-00003
• Device Sequence Number: 10878492
• Product Code: HQL
• UDI-Device Identifier: 00844369029582
• UDI-Public: 00844369029582
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2016

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: Physician
• Device Expiration Date: 01/20/2009
• Device Model Number: SOFTEC I
• Device Lot Number: 034719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2016
• Initial Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR