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

Model Number DCB00V

Device Problems Difficult to Fold, Unfold or Collapse (1254); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

It was reported that a recurring phenomenon was found by the surgeons: the two haptics were stuck together or just one was stuck.This took a few seconds to tens of seconds, delaying the end of the operation and requiring the use of a micromanipulator to help unfold the haptic.The micromanipulator is used in addition to the irrigation/aspiration handpiece to try to unblock the haptics by pushing them into the eye, which means extra handling and increased risks.No further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: date unknown, as information was requested but not provided.Section d4 - catalogue#: a complete catalogue # is unknown, as product serial number was not provided.Section d4 - serial#: unknown/ not provided.Section d4 - expiration date: unknown as product serial number was not provided.Section d4 - udi #: unknown as product serial number was not provided.Section d6a - implant date: unknown, as information was requested but not provided.Section d6b - explant date: not applicable, lenses remain implanted, therefor not explanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lenses (iol) were not returned for evaluation as they remain implanted.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h4 - device manufacture date: unknown as product serial number was not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: 17185840
• MDR Text Key: 318144534
• Report Number: 3012236936-2023-01413
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2023

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
• Device Operator: Health Professional
• Device Model Number: DCB00V
• Device Catalogue Number: DCB00V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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