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

Lot Number	170915
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inspected under a stereoscopic microscope set to 15x magnification.The lens was in one piece; one haptic was intact and the other haptic was missing.This haptic piece was not found anywhere in the returned packaging.The cross-sectional inspection of the broken haptic area was smooth and relatively straight.No other defects were noted.The cartridge used and lens are not compatible per ifu.A full audit of all batch documentation relating to the production of the devices was performed.The audit concluded that all procedures in manufacturing and packaging of the devices had been conducted correctly.Batch reconciliation was 100.0%.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.The visual examination carried out showed that the damage seen on the broken haptic suggests that it was either handled whilst in a dehydrated state or was caught in the cartridge.As such, lenstec recommends that the lens should not be held out of the saline solution for more than two minutes as recommended in the instructions for use.Lenstec also recommends that the user follows the instructions for use provided with the lens which indicates the compatible instruments and the procedure for correct implantation of the lens.
Event or Problem Description
Lenstec, inc.Received an email notification that " haptic torn off during insertion".

• 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: 7515887
• Report Number: 9613160-2018-00023
• Device Sequence Number: 2514979
• Product Code: HQL
• UDI-Device Identifier: 00844369029704
• UDI-Public: 00844369029704
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/15/2018

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: 04/11/2022
• Device Lot Number: 170915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1