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

Model Number	SOFTEC I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was received in the vial.The delivery system, outer pouch, instructions for use and label set were absent while the id card was enclosed in the outer box.The lens was inspected under a stereoscopic microscope set to x 10 magnification.The lens was badly damaged with one haptic completely ripped off and the other haptic partially hanging on.The cross-sectional inspection of both areas was jagged and it appeared that the lens was caught in these areas and tore.No other defects were noted.Additionally, there were no previous complaints received from this batch.A full audit of all batch documentation relating to the production of the lens was performed.The audit concluded that all procedures in manufacturing and packaging of the lenses had been conducted correctly.Batch reconciliation was 100.0%.Lenstec can confirm that this lens would not have passed our final clean and visual inspection criteria.Lenstec is unable to comment on the suitability of the imtec 30 cartridge used as this system is outside lenstec's validated parameters per the ifu.
Event or Problem Description
Lenstec was contacted by the facility stating "leading haptic broke in the eye; dr.Made larger incision to remove lens and inserted another lens in the same diopter size.The imtec 30 cartridge was used".

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• MDR Report Key: 7260962
• Report Number: 9613160-2018-00012
• Device Sequence Number: 11018649
• Product Code: HQL
• UDI-Device Identifier: 00844369029698
• UDI-Public: 00844369029698
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 06/01/2021
• Device Model Number: SOFTEC I
• Device Lot Number: 161205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1