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

Lot Number	172290
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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and the inspection was performed at lox magnification under a stereoscopic microscope.The edge of the optic carried a dig out where it appeared that the material was caught in this area and tore away from the remainder of the lens.In the same area as the dig out, the lens carried a straight cut through the optic material; this cut extended about 3/4 ways and appeared to have been done to facilitate lens removal.No other defects were noted on the lens.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 has carried out extensive testing on the cart45 s cartridges and the softec i lens; the performance and compatibility of these products have been verified.Additionally, the instructions for use provided with each lens indicates the correct method for implantation using the injection process and lenstec advises that the user follows these instructions which have been validated to prevent damage to either the cartridge or lens.(b)(4).
Event or Problem Description
Lenstec received an email with the following statement " crack noticed in the lens about halfway across and was removed".

• 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: 7470212
• Report Number: 9613160-2018-00021
• Device Sequence Number: 16169660
• Product Code: HQL
• UDI-Device Identifier: 00844369029520
• UDI-Public: 00844369029520
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/25/2018

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: 07/12/2022
• Device Lot Number: 172290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1