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

Lot Number	172291
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in the vial.The delivery system, outer pouch and instructions for use were absent while the label set and id card were enclosed in the outer box.The inspection was performed at x 10 magnification under a stereoscopic microscope.The lens was missing a haptic and this was not returned in the package.The optic of the lens carried a deep scratch which was made by a sharp instrument.One haptic was broken 3/4 of the way and the other haptic was intact.The cross-sectional inspection of the broken haptic was smooth and straight which is indicative of a snap.No other damage was seen on the lens.After having carried out a detailed investigation of the lens in question, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the results of the visual examination, the way the haptic was broken suggest that the lens was either handled whilst in a dehydrated state or was caught in the cartridge, indicative of user error and was reported as loading error by the facility.(b)(4).
Event or Problem Description
Lenstec received notification of a torn haptic, incision enlarged, lens removed.

• Brand Name: SOFTEC I
• Common Device Name: INTROCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• MDR Report Key: 7223059
• Report Number: 9613160-2018-00010
• Device Sequence Number: 19267941
• Product Code: HQL
• UDI-Device Identifier: 00844369029544
• UDI-Public: 00844369029544
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 07/03/2022
• Device Lot Number: 172291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/26/2018
• Patient Sequence Number: 1