MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model pcb00 intraocular lens (iol) was explanted from patient's right eye in a secondary surgical procedure because of residual astigmatism and decreased visual acuity.The replacement lens used is a different model but same diopter lens.No further information provided.
Additional Manufacturer Narrative
Device evaluation: as the product did not return for the evaluation, the complaint cannot be confirmed and either a product deficiency can be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaint folder has been created for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10865614
• Report Number: 2648035-2020-00876
• Device Sequence Number: 2521630
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)210108
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 01/08/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention