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

Lot Number	183057
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Red Eye(s) (2038)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the review conducted on this case, lenstec was unable to perform a more thorough investigation of the complaint as the lens remains implanted.Therefore, we are unable to comment on the nature of the reported incident described and cannot corroborate the claim of corneal edema or conjunctival congestion or make any definitive statement as to its cause.Additionally, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Furthermore, lenstec confirms that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.
Event or Problem Description
Lenstec received an email stating that "the (b)(6) yr.Old patient had conjunctival congestion and corneal edema on (b)(6) 2019.The complaint form received stated that the lens was still implanted, there was no patient injury or surgical intervention noted.

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 9324438
• Report Number: 9613160-2019-00028
• Device Sequence Number: 16734484
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 08/16/2023
• Device Lot Number: 183057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1