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 Date 05/22/2023

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) haptic was too glued on during implantation into the patient's eye.We have learned through follow up that the lens was successfully implanted.The iol remains in the patient's eye, the haptics were deployed but remained stuck for a few tens of seconds delaying the end of the operation and requiring the use of a micromanipulator to help lift them off.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 d6b - explant date: not applicable, as the lens remains implanted.Section e1: initial reporter first name: unknown, as information was asked but it was not provided.Section e1: email address: unknown/not provided, as information was asked but it was not provided.Section e1 - telephone number: (b)(6).Section g4: this report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dcb00 which is distributed in the united states under pma p980040.Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and 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 specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.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: 17159744
• MDR Text Key: 317950517
• Report Number: 3012236936-2023-01353
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636736
• UDI-Public: (01)05050474636736(17)260130
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/19/2023

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: DCB00V0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2023
• 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