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

Lot Number	181424
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After thorough investigation by the quality systems department, the results of lenstec's investigation are as follows; lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.The lens appeared to be handled whilst in a dehydrated state and this caused the break at the haptic.For this reason, lenstec recommends (following the dfu) that the lens should be implanted within two minutes of removal from the vial.Due to the hydrophilic nature of the lens, extended periods of time outside the saline will cause the lens to dehydrate and subsequently become damaged during the injection process.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "haptic broken during implantation, incision enlarged and lens removed.Another hd +17.0 was implanted to patient, closed with a stitch and no adverse event".

• Brand Name: SOFTEC HD
• 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: 8144019
• Report Number: 9613160-2018-00037
• Device Sequence Number: 11240331
• Product Code: HQL
• UDI-Device Identifier: 00844369027199
• UDI-Public: 00844369027199
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/07/2018

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: Health Professional
• Device Expiration Date: 06/19/2023
• Device Lot Number: 181424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1