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

Lot Number	F1298
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Deposits (1809)
Date of Event	06/19/2019
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 actual opacification or make any definitive statement as to its cause.However, we can confirm that a lens of this nature would not have been shipped.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.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.(b)(4).
Event or Problem Description
Lenstec received an email stating "cataract op on the left eye without complications on (b)(6) 2007, use of a monofocal iol +22.5 diopter.On (b)(6) 2019 finding that iol clouded on the left eye, iol exchange is required" the lens remains implanted.

• 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: 8916545
• Report Number: 9613160-2019-00022
• Device Sequence Number: 18961461
• Product Code: HQL
• UDI-Device Identifier: 00844369029544
• UDI-Public: 00844369029544
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

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: 04/14/2012
• Device Lot Number: F1298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1