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

Lot Number	171728
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Not Applicable (3189); No Information (3190)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After several attempts were made to the facility for information on the event, lenstec is unable to corroborate the claim and the lens remains implanted.Once additional information is received it will be reported as a supplemental mdr.However, a full audit of all batch documentation relating to the production of the lenses was performed.The audit concluded that all procedures in manufacturing and packaging of the lenses had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.We can find no evidence to suggest that there was any fault in the manufactured lens and there were no product deficiencies which would have led to this outcome.Lenstec also believes that the lens, the lens design and the manufacturing process were not at fault due to the extensive testing that we have performed on this model.
Event or Problem Description
Lenstec inc received an email stating an infection post operatively.However, after initial communication and request for additional information the clinic reported that no infection was present.Lenstec is awaiting additional information from the clinic to verify.No explants have taken place and lenstec cannot corroborate the complaint but reports as mdr currently.
Event or Problem Description
Lenstec inc received an email stating an infection post operatively.However, after initial communication and request for additional information the clinic reported that no infection was present.Additionally, lenstec received further information from the facility indicating that there was no post operative infection and there is no lens complaint.The lens remains implanted.
Additional Manufacturer Narrative
Further information provided from the facility stated that there was no post -operative infection in the patient and no lens complaint.The lens remains implanted.Based on the investigation previously carried out and the additional information received from the surgical site, lenstec concludes that there was no fault in the manufactured lens.

• Brand Name: SOFTEC HDO
• 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: 7545973
• Report Number: 9613160-2018-00026
• Device Sequence Number: 13782571
• Product Code: HQL
• UDI-Device Identifier: 00844369037433
• UDI-Public: 00844369037433
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 08/03/2022
• Device Lot Number: 171728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1