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

Model Number	SOFHDPLI+19.0D and PLITIP1645 Kit
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Additionally, no other complaints have been received from this batch.Lens remains implanted.
Event or Problem Description
Lenstec received an email stating " the surgery was completed on (b)(6) 2021, and the patient was found to have severe corneal edema on the next day.Local drops of 50% glucose injection were given acording to the doctors advice.The edema of the cornea was relieved and has now recovered well.".

• Brand Name: SOFTEC HD PLI
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 12240731
• Report Number: 9613160-2021-00019
• Device Sequence Number: 3612266
• Product Code: HQL
• UDI-Device Identifier: 00844369002479
• UDI-Public: 00844369002479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 12/14/2025
• Device Model Number: SOFHDPLI+19.0D and PLITIP1645 Kit
• Device Catalogue Number: SOFTEC HD PLI
• Device Lot Number: SB10749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1