MAUDE Adverse Event Report: ALLERGAN, INC US REFRESH CONTACTS 510(K); CARMELLOSE SODIUM

Lot Number T2425

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

An initial spontaneous report from the united states was received originating from a consumer on (b)(6) 2022 regarding a patient of unknown age and gender who had wrong technique in product usage process, poor quality product administered, product contamination, and product delivery mechanism issue associated with us refresh contacts 510(k) (carmellose sodium) for "unknown indication" as prescribed.Allergan received the report on 25-feb-2022.Medical history was not reported.Concomitant medications were not reported.No dosage information was reported for us refresh contacts 510(k) (carmellose sodium) (eye drops, solution).The lot number was reported as: t2425 (expiry date: 29-mar-2024).On an unknown date, the patient experienced "dirt clump that had fallen /pin came out black" (product contamination), "popped the top off and poured it into my eye / tip of the pin came out black" (poor quality product administered), "popped the top off turned it upside down into eye and poured it out/ get a pin and poke it around inside the tip." (wrong technique in product usage process), and "wouldn't squeeze out / wouldn't squeeze out" (product delivery mechanism issue).This case was considered non-serious.Reportedly, refresh contacts was getting low but still had liquid inside, it wouldn't squeeze out.The patient shook it and could hear plenty in there.The patient tried for a couple of days but nothing would came out.The patient decided to pop the top off and turned it upside down into eye and it poured out.The patient noticed some type of dirt clump that had fallen into my sink.The next day the patient attempted to squeeze it out again.The patient popped again the top off and poured it into eye.The patient thought to get a pin and poke it around inside the tip.The tip of the pin came out black.The patient threw it away.Laboratory tests were not reported.Action taken with the suspect drug us refresh contacts 510(k) was unknown.

Event Description

A follow-up spontaneous report (regulatory no: 000000-2022-00001) from the united states was received originating from a consumer on 08-apr-2022 regarding a patient of unknown age and gender who had wrong technique in product usage process, poor quality product administered, product contamination, and product delivery mechanism issue associated with us refresh contacts 510(k) (carmellose sodium) for "unknown indication" as prescribed.Allergan received the report on 08-apr-2022.Medical history was not reported.Concomitant medications were not reported.No dosage information was reported for us refresh contacts 510(k) (carmellose sodium) (eye drops, solution).The lot number was reported as: t2425 (expiry date: 29-mar-2024).On an unknown date, the patient experienced "dirt clump that had fallen /pin came out black" (product contamination), "popped the top off and poured it into my eye / tip of the pin came out black" (poor quality product administered), "popped the top off turned it upside down into eye and poured it out/ get a pin and poke it around inside the tip." (wrong technique in product usage process), and "wouldn't squeeze out / wouldn't squeeze out" (product delivery mechanism issue).This case was considered non-serious.Reportedly, refresh contacts was getting low but still had liquid inside, it wouldn't squeeze out.The patient shook it and could hear plenty in there.The patient tried for a couple of days but nothing would came out.The patient decided to pop the top off and turned it upside down into eye and it poured out.The patient noticed some type of dirt clump that had fallen into my sink.The next day the patient attempted to squeeze it out again.The patient popped again the top off and poured it into eye.The patient thought to get a pin and poke it around inside the tip.The tip of the pin came out black.The patient threw it away.Laboratory tests were not reported.Action taken with the suspect drug us refresh contacts 510(k) was unknown.Tracking of changes: 24-feb-2022: initial source documents received.08-apr-2022: additional information received: evaluation codes added.

Manufacturer Narrative

The defect reported was not confirmed after retain testing and the review of the batch record.For this lot, no applicable deviation was reported.Complaint sample is not available for evaluation.No assignable cause attributable to our processes was determined while the product was under our control.Per pmq-08-05-sop-002 the final risk of this record falls within the low category.No similar complaints of this nature have been received for this lot.There have been received 15 foreign substances-product complaints against this product in the past 12 months.No corrective or preventive action is needed for this complaint.Will continue monitoring this complaint code.

Event Description

A follow-up spontaneous report (regulatory no: 000000-2022-00001) from the united states was received originating from a consumer on 14-apr-2022 regarding a patient of unknown age and gender who had wrong technique in product usage process, poor quality product administered, product contamination, and product delivery mechanism issue associated with us refresh contacts 510(k) (carmellose sodium) for "unknown indication" as prescribed.Allergan received the report on 14-apr-2022.Medical history was not reported.Concomitant medications were not reported.No dosage information was reported for us refresh contacts 510(k) (carmellose sodium) (eye drops, solution).The lot number was reported as: t2425 (expiry date: 29-mar-2024).On an unknown date, the patient experienced "dirt clump that had fallen /pin came out black" (product contamination), "popped the top off and poured it into my eye / tip of the pin came out black" (poor quality product administered), "popped the top off turned it upside down into eye and poured it out/ get a pin and poke it around inside the tip." (wrong technique in product usage process), and "wouldn't squeeze out / wouldn't squeeze out" (product delivery mechanism issue).This case was considered non-serious.Reportedly, refresh contacts was getting low but still had liquid inside, it wouldn't squeeze out.The patient shook it and could hear plenty in there.The patient tried for a couple of days but nothing would came out.The patient decided to pop the top off and turned it upside down into eye and it poured out.The patient noticed some type of dirt clump that had fallen into my sink.The next day the patient attempted to squeeze it out again.The patient popped again the top off and poured it into eye.The patient thought to get a pin and poke it around inside the tip.The tip of the pin came out black.The patient threw it away.Laboratory tests were not reported.Action taken with the suspect drug us refresh contacts 510(k) was unknown.Tracking of changes: 24-feb-2022: initial source documents received.08-apr-2022: additional information received: evaluation codes added.14-apr-2022: additional information received: evaluation codes added.

Manufacturer Narrative

Pr id: (b)(4).Argus id / tms #: case num | tms num: 2207008us |.Assigned to: (b)(6).Short description: refresh contacts 12 ml, lot t2425, foreign substance - product.Date received: 2022-2-24.Country of incident: us.Type: foreign substance.Complaint nature: foreign substance - product.Number of units affected: 1.Product description (cr): refresh contacts 12 ml.Product lot # (cr): t2425.Product expiration date (cr): 03/29/2024.Product site of mfg.(cr): waco(export dist./mfg).Description: 28-feb-2022: received email from med info on 25-feb-2022, case (b)(4).On 24-feb-2022, med info received an email from a consumer, who wrote, "i would like to inform you that as my bottle of refresh contacts was getting low but still had liquid inside, it wouldn't squeeze out.So, i shook it & could hear plenty in there.I tried for a couple of days but nothing would come out (gtw 458701).Then i decided to pop the top off.I turned it upside down into my eye & it poured out.Then i noticed some type of dirt clump that had fallen into my sink.I thought surely it didn't just come out of the bottle of eye drops yet i suspected it did.The next day i attempted to squeeze it out again.Nothing.So, i again popped the top off & poured it into my eye.Then i thought to get a pin & poke it around inside the tip.The tip of the pin came out black.Ugh.(gtw 458703) i threw it away.I suggest you check lot t2425 mar 24." (jb).7-mar-2022 : upon completion of initial reportability assessment, this complaint was found to be reportable per fda cfr 21 part 4 combination product reporting and argus case link is required.(mmw).Root cause grid: cause category: no lab assignable cause; cause type: no lab assignable cause; cause sub-category: no lab assignable cause; comment: n/a.Root cause analysis: on (b)(6) 2022 an evaluation was performed and based upon complaint description and available information from complaint record this individual event does not meet field alert report criteria.On 01 mar 2022 a management assessment was completed.The available information for this complaint has been reviewed.No additional actions were completed at this stage until further information is available.Based on the assigned complaint type/nature, the investigation plan should include the following: batch review and bioburden analysis of a retain sample.On 11 mar 2022 was performed a review of batch t2425.Material number: 94019-2.Material name: refresh contacts 12ml (subassembly).Process step: fill.Formula: 9329x.Production date: 30mar2021.Line: md3.Ecr/eco version: 3.0.Any non-conformance/lir/oos noted: no.Any in-process inspection defects noted: no.Any associated lots: no.No specific cause for foreign substance-product was identified during the batch record review.On 15 mar 2022, one retain unit (bottle) was tested for bioburden.The bottle was visually inspected and the retain sample cultured to identify any bacterial or fungal growth present in the solution or on the cap or the tip of the bottle.The flow was unobstructed through the tip of the unit, the solution appeared clear, and no particles were observed in the solution.No fungal or bacterial growth was recovered from the solution, tip, or cap.Sample was within specification.Complaint confirmed?: no.Risk level - final: low.Closure summary & action plan: the defect reported was not confirmed after retain testing and the review of the batch record.For this lot, no applicable deviation was reported.Complaint sample is not available for evaluation.No assignable cause attributable to our processes was determined while the product was under our control.Per pmq-08-05-sop-002 the final risk of this record falls within the low category.No similar complaints of this nature have been received for this lot.There have been received 15 foreign substances-product complaints against this product in the past 12 months.No corrective or preventive action is needed for this complaint.Will continue monitoring this complaint code.Date closed: 15-apr-2022.

• Brand Name: US REFRESH CONTACTS 510(K)
• Type of Device: CARMELLOSE SODIUM
• Manufacturer (Section D): ALLERGAN, INC; 2525 dupont drive; irvine CA 92623 9534
• Manufacturer Contact: 2525 dupont drive; irvine, CA 92623-9534
• MDR Report Key: 13913046
• MDR Text Key: 295324634
• Report Number: 0001643525-2022-00001
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

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 Expiration Date: 03/29/2024
• Device Lot Number: T2425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/14/2022; 04/14/2022
• Supplement Dates FDA Received: 04/13/2022; 04/27/2022
• 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