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

Lot Number	191817
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
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 exudative proliferative membrane 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, the investigation and assessment from the medical monitor indicate there is no evidence to suggest that the incident was lens related.
Event or Problem Description
Lenstec received an email stating that "there were two patients who had the symptoms of exudative proliferative membrane in front of the intraocular lens after implanting softec hd for 4-8 days.All lenses remain implanted.

• 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: 9506924
• Report Number: 9613160-2019-00038
• Device Sequence Number: 2086107
• Product Code: HQL
• UDI-Device Identifier: 00844369027359
• UDI-Public: 00844369027359
• 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): 12/20/2019

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: 05/29/2024
• Device Lot Number: 191817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1