MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. CONSEPT 1-STEP; ACCESSORIES, SOFT LENS PRODUCTS

Model Number 9081X

Device Problems Component Missing (2306); Device Markings/Labelling Problem (2911); Packaging Problem (3007)

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

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: unknown/no information provided.Based on the kitted lot number zj07551, the lot number for the tablets is 95622.Presently, the information correlated to this lot number is unavailable as the product is manufactured externally.The lot number for the tablets was determined by the returned product kit lot number.Therefore, the following information provided in is for the kit lot number zj07551.Expiration date: the date provided reflects information for the kit lot number zj07551.Unique identifier (udi) number: the udi# provided is for the kit lot number zj07551 as the udi for the tablets has not been provided.Device manufacture date: the date provided in section reflects information for the kit lot number zj07551.Implant date: if implanted; give date: not applicable as tablets are not an implantable device.Explant date: if explanted; give date: not applicable as tablets are not an implantable device, therefore, not explantable.Device manufacture date: the date provided reflects information for the kit lot number zj07551.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Consumer reported that the primary packaging of one of the neutralizing foil sheets had a manually cut off area where the lot number was supposed to be printed.Additionally, there were three tablets missing.The foil had 12 out of 15 tablets present.The consumer was unable to confirm the lot number on the primary packaging because it had been discarded.They remembered that the label on the box had no issues.The remaining five sheets from the same box also had no labeling issues and were used with no problems.However, because the sheets were discarded the lot number could not be confirmed.The consumer used four(4) tablets from the suspect foil sheet without any issues.Reportedly, the label was missing only on the one tablet sheet.Consumer reported that there was no sign of the box or blister card of neutralizing tablets having been opened.There were no patient injuries reported.No further information was provided.

Manufacturer Narrative

Section d4 expiration date: august 2023, no day provided by the external manufacturer.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: june 10, 2022.Section h3: evaluated by manufacturer: yes.Section h4 device manufacture date: september 2021, no day provided by the external manufacturer.Device evaluation: the return sample was received jun 10, 2022.The returned sample consists of a defective blister (12 pocket blister) of unknown batch, consisting of 05 tablets in sealed pockets while 07 pockets are found in an opened condition without tablets.The received blister was found cut from one end in such a way that, 03 of the tablets pockets along with embossing portion having batch details on blister are missing.Although, the lot number was not on the foil strip; based on the kit product lot number (zj07551) received from the customer the tablet lot number is 95622.The retain sample for lot number 95622 was analyzed and no abnormality was observed.The retain blister packs had 15 pockets and were embossed with lot number 95622 and expiration date 2023/08.In comparison of the retained and returned complaint sample, a sharp, straight cut was observed on the complaint sample blister, while curve cut is made on blisters which are produced from machine, as seen in retention sample blister.Thus it is concluded that the sharp, straight cut on the complaint blister was not produced by blister packing machine.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.The complaint log for the past two years from the date of receipt of the complaints has been reviewed and no justified complaint of similar nature was found.Conclusion: based on the investigation it is concluded that the complaint is not generated due to any quality issue / operational issue in packing operation of the complaint batch.The product is packed in blisters and then secondary packaging is performed as loose / bulk packing trays.Further re-packaging of loosely packed blister is performed at the other site of j&j.Hence probability of generation of complaint due to improper handling at other site of j&j cannot be ruled out.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Manufacturer Narrative

Correction: this is to correct the mdr follow-up #1, section h10 conclusion which states: hence probability of generation of complaint due to improper handling at other site of j&j cannot be ruled out.The correct entry in section h10 conclusion is: hence, change of generation of defect due to mishandling at patient end cannot be completely ruled out.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: CONSEPT 1-STEP
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14721940
• MDR Text Key: 294264523
• Report Number: 3012236936-2022-01425
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 14987617002012
• UDI-Public: (01)14987617002012(17)230831(10)ZJ07551
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 9081X
• Device Catalogue Number: 40840WW
• Device Lot Number: 95622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male