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

Model Number	SOFTECI+19.5
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the device was conducted correctly.The visual examination carried out revealed that the broken haptic was probably as a result of the lens being handled whilst in a dehydrated state during the implantation.Lenstec therefore 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.The damage on the optic area was probably as a result of the lens being removed from the eye.The lc 16 cartridge used is compatible with the +19.5d softec i lens and once the instructions for use are followed, proper ejection of the lens in the eye should occur.(b)(4).
Event or Problem Description
Lenstec received an email stating ' lens was put into patients eye then removed.No injury.Cartridge malfunction.'.

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10227911
• Report Number: 9613160-2020-00057
• Device Sequence Number: 16942511
• Product Code: HQL
• UDI-Device Identifier: 00844369029421
• UDI-Public: 00844369029421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: Health Professional
• Device Expiration Date: 11/25/2024
• Device Model Number: SOFTECI+19.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 194032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1