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

Model Number	DCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Explant date: not applicable as the iol was not explanted.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Report received indicating the cartridge of the dcb00 (preloaded device) cracked as the intraocular lens (iol) was being inserted into the left eye.Surgeon noticed the tip was cracked while inserting.The iol was placed in another cartridge and was inserted in the eye with no problems.No incision enlargement required.The iol remains implanted.No further information was provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 01/23/2021.Section h3: device returned to manufacturer: yes.Device evaluation the plunger and pushrod was observed in advanced position.Residues of lubricant material was observed on cartridge.The cartridge tip was observed deformed and crack.The lens was not returned, its still implanted.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported as cartridge crack was not verified, tip deformed/crack was verified.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.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 SIMPLICITY 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: 11098757
• Report Number: 2648035-2020-00975
• Device Sequence Number: 11670249
• Product Code: HQL
• UDI-Device Identifier: 05050474636262
• UDI-Public: (01)05050474636262(17)230925
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1