MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DCB00

Device Problems Crack (1135); Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge.The cartridge and cartridge tip were cracked in the same location that the lens was located.The handpiece was disassembled and the assembly was inspected, no issues that could contribute to or cause the observed issues could be identified.The lens was removed from the cartridge and cleaned, revealing that it was torn and damaged in a way consistent with a lens that was folded in the cartridge.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional investigation request (ir) for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency or malfunction.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 Description

It was reported that the preloaded device cartridge broke/ cracked.The intraocular lens (iol) was partially inserted into patient's left eye, however, was removed.Another lens of same model and diopter was used as the replacement.No other intervention was required.Product investigation confirmed that cartridge tip was cracked.No other information was provided.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15414309
• MDR Text Key: 306178111
• Report Number: 3012236936-2022-02244
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)240911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male